Devices and methods for the treatment of vascular defects

ABSTRACT

Devices and methods for treating vascular defects, such as, for example, balloon-type aneurysms, are described herein. In one embodiment, an apparatus includes an insertion portion and an expandable implant. The expandable implant is configured to be deployed in an aneurysm and is coupled to the insertion portion. The expandable implant has a first portion and a second portion coupled to the first portion. The expandable implant is movable between a first configuration in which the first portion and the second portion are substantially linearly aligned and a second configuration in which the second portion at least partially overlaps the first portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/147,883, filed Oct. 1, 2018, which is a continuation of U.S. patentapplication Ser. No. 15/846,964, filed Dec. 19, 2017, now U.S. Pat. No.10,675,037, which is a continuation of U.S. patent application Ser. No.15/162,073, filed May 23, 2016, now U.S. Pat. No. 10,064,627, which iscontinuation of U.S. patent application Ser. No. 14/661,233, filed Mar.18, 2015, now U.S. Pat. No. 9,855,051, both of which are continuationsof U.S. patent application Ser. No. 13/727,029, filed Dec. 26, 2012, nowU.S. Pat. No. 8,998,947, which is a continuation-in-part of U.S. patentapplication Ser. No. 13/421,122, filed Mar. 15, 2012, now abandoned,which is a continuation-in-part of U.S. patent application Ser. No.13/230,628, filed Sep. 12, 2011, now U.S. Pat. No. 8,974,512, whichclaims priority to and the benefit of U.S. Provisional PatentApplication No. 61/381,770, filed Sep. 10, 2010. All of the foregoingdisclosures are hereby incorporated by reference herein in theirentireties.

BACKGROUND

The invention relates generally to medical devices and more particularlyto expandable medical devices and methods for treating vascular defects.For example, the invention can relate to expandable medical devices andmethods for treating an aneurysm. Aneurysms are dilations in a bloodvessel caused from weakening of a blood vessel wall. The dilation isproduced by the pressure exerted by normal blood flow, which can causethe weakened segment of the blood vessel to swell. In some cases, thisswelling results in a sac, or balloon-like polyp protruding from themain or parent vessel. Continued growth and/or eventual rupture of theballooned arterial wall can have devastating results for a patient. Assuch, unruptured aneurysms should be treated to prevent hemorrhage.Additionally, ruptured aneurysms can be treated to avert a subsequentrupture and/or additional damage.

Some known medical devices and treatment methods used for treating ananeurysm include delivering a platinum coil to the sac of the aneurysm.The platinum coil is electrolytically separated from a delivery wire,thus inducing a charge in the coil which can cause a thrombotic effectin the aneurysm. In known procedures, about 30% of the volume of theaneurysm is packed with coils. Such known devices and methods, however,often have an about 30% recanalization rate, meaning blood flow returnsto the aneurysm again and can cause the coil-packed aneurysm to swellfurther. Additionally, such known devices and methods require prolongedprocedure times for the patient and correspondingly increased exposureto radiation for the patient. Moreover, such devices and methods do nottreat the neck of the aneurysm, which is the area between the parentblood vessel and the sac of the aneurysm.

Another known treatment method includes the use of both a coil and astent. The coil is delivered to the sac of the aneurysm as describedabove, and the stent is positioned within the parent blood vessel suchthat a portion of the stent is disposed over the neck of the aneurysm.Such procedures have several drawbacks. For one, delivery of twoseparate types of devices (i.e., coil(s) and a stent) is a more complexprocedure, often resulting in a longer procedure time for the patient.The stent may lead to intra-stent stenosis of the blood vessel.Additionally, a patient would likely be required to take a blood thinnerindefinitely following the procedure. Moreover, such devices and methodsare not suitable for treatment of aneurysms positioned at a bifurcationof the blood vessel (i.e., between adjacent branches of a vessel).

Another known device and treatment method includes the use of a flowdiverter delivered to the parent blood vessel adjacent the neck of theaneurysm. Generally, the flow diverter is positioned within the parentblood vessel over the neck of the aneurysm to prevent additional bloodflow into the aneurysm from the vessel. In current procedures, more thanone flow diverter is required per aneurysm to ensure blood flow isappropriately diverted from the aneurysm. Such a device and treatmentmethod has similar drawbacks to the use of a stent, described above.Specifically, the flow diverter may lead to stenosis of the blood vesseland the patient would likely be required to take a blood thinnerindefinitely following the procedure. Additionally, known flow divertersare not suitable for treating an aneurysm positioned at a bifurcation ofthe blood vessel. Moreover, long term follow-up of patients treatedusing a flow diverter is showing an increased rate of recanalization tothe aneurysm.

Thus, there is a need for improved systems, devices and methods fortreating vascular defects, such as balloon-type aneurysms, as describedherein.

SUMMARY

Devices and methods for treating vascular defects, such as, for example,balloon-type aneurysms, are described herein. In one embodiment, anapparatus includes an insertion portion and an expandable implant. Theexpandable implant is configured to be deployed in an aneurysm and iscoupled to the insertion portion. The expandable implant has a firstportion and a second portion coupled to the first portion. Theexpandable implant is movable between a first configuration in which thefirst portion and the second portion are substantially linearly alignedand a second configuration in which the second portion at leastpartially overlaps the first portion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a medical device according to anembodiment in a first configuration.

FIG. 2 is a schematic illustration of a medical device according to anembodiment in a second configuration.

FIG. 3 is a side view of a medical device according to an embodiment ina first configuration.

FIG. 4 is a side view of a medical device according to an embodiment ina second configuration.

FIG. 5A is a view of the medical device of FIG. 3 in a firstconfiguration during insertion into an aneurysm.

FIG. 5B is a view of the medical device of FIG. 3 in a secondconfiguration during insertion into an aneurysm.

FIG. 5C is a view of the medical device of FIG. 3 in a thirdconfiguration during insertion into an aneurysm.

FIG. 6 is a view of a portion of a medical device in an expandedconfiguration, according to an embodiment.

FIGS. 7-13 are views of a medical device in an expanded configuration,according to embodiments.

FIG. 14 is a view of a medical device in a partially collapsedconfiguration, according to an embodiment.

FIG. 15 is a view of the medical device of FIG. 14 in an expandedconfiguration, according to an embodiment.

FIG. 16 is a view of a portion of a medical device in an expandedconfiguration according to an embodiment, with a first portion spacedapart from a second portion.

FIG. 17A is a view of a portion of a medical device in a collapsedconfiguration according to an embodiment.

FIG. 17B is a view of a portion of a medical device in an expandedconfiguration according to an embodiment.

FIG. 18 is a flowchart of a method according to an embodiment.

FIG. 19A is a view of a portion of a medical device in an expandedconfiguration, according to an embodiment.

FIG. 19B is a schematic illustration of the medical device of FIG. 19A.

FIG. 20 is a view of a portion of a medical device in an expandedconfiguration, according to an embodiment.

FIG. 21 is a view of a portion of a medical device in an expandedconfiguration, according to an embodiment.

FIG. 22 is a view of a portion of the medical device of FIG. 21 in acollapsed configuration.

FIG. 23 is a view of a portion of a medical device in a collapsedconfiguration, according to another embodiment.

FIG. 24 is a view of the portion of the medical device. of FIG. 23 in anexpanded configuration.

FIG. 25 is a view of a portion of a medical device in a collapsedconfiguration, according to an embodiment.

FIG. 26 is a view of the portion of the medical device of FIG. 25 in apartially expanded configuration.

FIG. 27 is a view of a portion of the medical device of FIG. 25 in anexpanded configuration.

FIGS. 28 and 29 are each a different view of a portion of a medicaldevice in an expanded configuration, according to an embodiment.

FIGS. 30 and 31 are each a view of a portion of a medical device in anexpanded configuration, according to different embodiments.

FIG. 32 is a view of a portion of a medical device in a collapsedconfiguration, according to an embodiment.

FIG. 33 is a view of the portion of the medical device of FIG. 32, shownin an expanded configuration.

FIG. 34 is a schematic illustration of the portion of the medical deviceof FIG. 33.

FIG. 35 is a schematic illustration of a portion of an insertion device,according to an embodiment, shown in a first configuration and coupledto a schematic illustration of a portion of an expandable implant.

FIG. 36 is a schematic illustration of the portion of the insertiondevice and expandable implant of FIG. 35, shown in a secondconfiguration.

FIG. 37 is a schematic illustration of the portion of the insertiondevice of FIG. 35 shown removed from the expandable implant.

FIG. 38 is a schematic illustration of a portion of an insertion device,according to another embodiment.

FIG. 39 is a view of a portion of an insertion device, according toanother embodiment.

FIG. 40 is a schematic illustration of a portion of an insertion devicecoupled to an expandable implant, according to another embodiment.

FIG. 41 is a flowchart illustrating a method of deploying an expandableimplant, according to an embodiment.

FIG. 42 is a view of a portion of a medical device in an expandedconfiguration, according to an embodiment.

FIG. 43 is a view of a portion of the medical device of FIG. 42 in acollapsed configuration.

FIG. 44 is a view of a portion of a medical device in an expandedconfiguration, according to an embodiment.

FIG. 45 is a view of a portion of the medical device of FIG. 44 in acollapsed configuration.

FIG. 46 is a view of a portion of the medical device of FIG. 44 shownpartially deployed within an aneurysm.

FIGS. 47-54 are each a schematic illustration of a portion of aninsertion device, according to a different embodiment.

FIG. 55 is a side view of a portion of an insertion device according toan embodiment.

FIG. 56 is a side view of a portion of the insertion device of FIG. 55shown coupled to an expandable implant.

FIG. 57 is a view of a portion of a medical device, shown partiallydeployed, according to another embodiment.

FIG. 58 is a schematic illustration of a portion of a medical deviceshown in a collapsed configuration, according to another embodiment.

FIG. 59 is a view of the portion of the medical device of FIG. 58, shownin an expanded configuration.

FIG. 60 is a schematic illustration of a portion of an expandableimplant, according to another embodiment, shown in a collapsedconfiguration.

DETAILED DESCRIPTION

Medical devices and methods of treatment are described herein to treatpatients experiencing a vascular defect, such as an aneurysm, in acirculatory blood vessel and the effects of that defect, includinghemorrhagic stroke. For example, the devices and methods describedherein can be useful for treating vascular defects present invasculature that is tortuous, of small-diameter, and/or that isotherwise difficult to access. More specifically, the devices andmethods described herein can be useful for treating saccular (alsoreferred to as balloon-type or berry) aneurysms, bifurcation aneurysms,fistulas, and other defects in vasculature, including defects inneurovasculature. The medical devices and methods of treatment describedherein can reduce hemorrhagic events while promoting endothelializationof an opening between an aneurysm and a parent blood vessel from whichthe aneurysm bulge formed (e.g., at a neck of the aneurysm).

Various embodiments of a medical device for occupying all orsubstantially all of the volume of an aneurysm and/or promotingendothelialization at or proximate to the aneurysm are described herein.In some embodiments, the medical device includes an expandable implantincluding an electropositive woven or braided material. The filaments orstrands forming the braid or weave are configured to encouragerecruitment and/or retention of endothelial cells to the device andtherefore within the defect. The expandable implant is configured toassume a non-linear predetermined three-dimensional shape within a sacof the aneurysm upon release from a tubular or other delivery constraint(e.g., a catheter or cannula). The electropositive woven or braidedmaterial has a particular porosity and includes multiple openingsbetween the filaments or strands when the expandable implant is in theexpanded configuration. Such openings are ideal in the blood environmentfor harboring endothelial cells recruited to the site. Theelectropositivity of the material encourages endothelialization in thepresence of the electronegative charges of the blood and body tissues.Said another way, the electropositivity of the expandable implant inrelation to a charge of blood and tissue (which is electronegative incomparison) provides an environment in the defect that promotesendothelialization. Endothelialization within the defect can ultimatelyresult in the defect walling-off from the parent vessel. For example,the growth and development of an endothelial layer over a neck of ananeurysm can wall off the aneurysm from the parent vessel and allow flowdynamics to equilibrate at the defect. As such, the device can beconfigured to facilitate healing the defect and preventingrecanalization because tissue is created from within the body thatresists aberrant blood flow and redistributes the flow pressure that mayhave created the defect. Upon healing with endothelialization, thepressure is evenly distributed along the parent vessel in a manner thatprecludes recanalization at the defect post-treatment. Furthermore,blood from within the parent vessel no longer has access to the walledoff defect once the endothelialization process is complete.Additionally, at least a portion of the expandable implant can bepositioned over the neck of the aneurysm once the implant is deployedwithin the aneurysm such that the portion disrupts the flow of bloodfrom the parent vessel into the aneurysm. As such, the expandableimplant provides blood flow disruption in advance of and in addition togrowth and development of the endothelial layer over the neck of theaneurysm.

A medical device described herein can include an insertion portion(e.g., a guide wire) and an expandable implant formed with, for example,woven or braided filaments in a mesh-like configuration. The terms meshand braid can each refer herein to a fabric or material of woven orbraided filaments or strands of wire or polymer. The expandable implantof the medical device can be configured to compress or collapse fordelivery into a blood vessel. In some embodiments, the medical devicecan be inserted while in a collapsed or compressed configuration througha delivery device, such as, for example, a microcatheter, cannula,delivery tube or sheath. In some embodiments, the medical device can bedeployed without the use of such a delivery device.

The expandable implant of the medical device can have a collapsed orcompressed configuration such that the expandable implant has a diameterthat can fit within the narrow constraints of the neurovasculatureand/or within a lumen of a delivery catheter. The expandable implant ofthe medical device can be formed with, for example, an arrangement ofstrands (e.g., a mesh or braid arrangement of strands or filaments) thatcan compress and expand. Such materials include Nitinol, MP35N,stainless steel, cobalt chromium, titanium, platinum, tantalum,tungsten, or alloys thereof, or polyester, polyethylene (PET), Dacron,PEEK, vectron, and suture materials, and are available from Fort WayneMetals of Fort Wayne, Ind., California Fine Wire Company of GroverBeach, Calif., other metal manufacturers, Ethicon Inc. of Somerville,N.J., Genzyme of Cambridge, Mass., Poly-Med, Inc. of Anderson, S.C.,and/or other medical grade suture and fiber manufacturers. Theexpandable implant can be compressed over and/or along the insertionportion of the medical device. The insertion portion can be, forexample, a wire. In some embodiments, a medical device includes aninsertion portion movably disposable within a lumen of a deliverydevice. A distal portion of the insertion portion can be coupled to theexpandable implant. The expandable implant can be moved from a collapsedconfiguration to an expanded configuration while disposed within, or asit is being inserted into, a defect (e.g., an aneurysm).

In some embodiments, the expandable implant can be formed with filamentsof superelastic or shape memory material (such as, e.g., nitinol) andthe braid or mesh can be set in a predefined shape prior to attachingthe expandable implant to the insertion portion of the medical device.In such an embodiment, when the expandable implant is deployed andexpands, it assumes a biased predetermined shape. The predeterminedshape can be a generic shape, such as that of a sphere, or can be acustom-made shape based on a shape of a target aneurysm within apatient. Suitable materials are described in more detail herein.

The medical devices described herein can include one or more expandableimplants formed with a woven mesh or braid that has variably sizedapertures (also referred to herein as “openings” or “pores”). Saidanother way, the devices are formed with a material that has aparticular porosity or pore density. In some embodiments, an expandableimplant can have sections of mesh or braid having variation in densityof the filaments and may include portions or bands of densely spacedfilaments (i.e., lower porosity) spaced by portions or bands that areless dense (i.e., higher porosity). The less dense braid portion canhave larger openings in the braid, while the more dense braid portioncan have smaller openings in the braid. Material (e.g., bodily tissuesuch as endothelial cells) can be encouraged to enter and/or attach tointerstices of the mesh of the expandable implant. For example, the moredense braid portion can be used to encourage greater endothelial cellattachment and the less dense braid portion can be used to reduce theoverall weight and or material to be implanted in the patient. The lessdense sections can also direct the final shape of the expandableimplant. For example, sections of less dense (more open) mesh or braidcan direct the effects of expansion of the implant.

In some embodiments, a medical device can be delivered to a desiredtreatment site within a vasculature by inserting the medical devicethrough a lumen of a delivery catheter (e.g., a microcatheter). Theexpandable medical device can be inserted through the delivery catheterin a collapsed or compressed configuration. The expandable implant ofthe expandable medical device can be moved out through a distal end ofthe delivery catheter at the treatment site (e.g., into a sac of ananeurysm) and moved to an expanded configuration. In some embodiments,the delivery catheter is used to compress or collapse the expandableimplant. For example, the expandable implant can be formed with a biasedexpanded configuration and when it is placed within a lumen of acatheter it is compressed. When the expandable implant is moved outsideof the catheter, it can assume its biased expanded configuration. In theexpanded configuration, a first portion of the expandable implantsubstantially overlaps a second portion of the expandable implant. Thefirst and second portions of the expandable implant can be discretestructures or can be portions of a unitary or monolithically constructeddevice.

A medical device, such as an expandable implant, described herein caninclude a first porous member and a second porous member coupled to thefirst porous member. Each of the first and second porous membersincludes a first end and a second end. The first and second porousmembers each have a collapsed configuration for insertion through ablood vessel and an expanded configuration for occupying at least aportion of the volume defined by the sac of an aneurysm. In someembodiments, the first porous member is substantially elongate and has agreater width in its expanded configuration than in its collapsedconfiguration. The second porous member is substantially elongate andhas a greater width in its expanded configuration than in its collapsedconfiguration. In some embodiments, the width of the first porous memberis greater than the width of the second porous member, for example, wheneach of the first and second porous members are in their expandedconfigurations.

In some embodiments, the first porous member is configured to occupy afirst volume in its collapsed configuration and a second, greater,volume in its expanded configuration. For example, the first porousmember can have a substantially spherical, oblong, or other suitableshape in its expanded configuration that occupies a greater volume thanthe substantially elongate shape of the first porous member in itscollapsed configuration. The second porous member can be configured tomove or curve into a three dimensional configuration in the expandedconfiguration such that a first segment of the second porous memberoverlaps with a second segment of the second porous member. In itsexpanded configuration, the second porous member can define an interiorregion configured to receive the first porous member in its expandedconfiguration. For example, in some embodiments, the second porousmember has a substantially spherical shape with an open interior regionconfigured to receive the first porous member.

In some embodiments, a medical device, such as an expandable implant,described herein can include a first porous member and a second porousmember. Each of the first and second porous members includes a first endand a second end. The first and second porous members each have acollapsed configuration for insertion through a blood vessel and anexpanded configuration for occupying at least a portion of the volumedefined by a sac of an aneurysm. The first and second porous members areeach substantially elongate in the collapsed configuration. In itsexpanded configuration, the first porous member has a three-dimensionalshape including a first segment configured to overlap with a secondsegment and defining an interior region. The second porous member isconfigured to be disposed in the interior region of the first porousmember when each of the first and second porous members is in theirrespective expanded configurations. In some embodiments, the secondporous member can be formed integrally or monolithically with the firstporous member. In some embodiments, the second porous member can bewoven or braided using the same filaments that form the first porousmember.

In some embodiments, the expandable implant is in the form of a braidedtube that includes fibers of a superelastic shape memory alloy, orpolymeric fibers. In some embodiments, the expandable implant can effecta shape deformation inducing a substantially spherical contour. In someembodiments, the expandable implant can effect a shape deformationinducing a helical contour. In some embodiments, the shape deformationcan include inducing radial expansion and/or axial shortening.

The medical devices described herein can be used to occupy at least aportion of the volume defined by a sac of an aneurysm and/or to promoteendothelialization of the neck of the aneurysm to inhibit or stop bloodflow into the aneurysm, which can lead to, for example, hemorrhagicstroke. In some embodiments, wire or polymer filaments can be used toform a woven mesh or braided strands that can be expandable, and haveapertures sized to promote endothelial cell attachment at the aneurysm.

It is noted that, as used in this written description and the appendedclaims, the singular forms “a,” “an” and “the” include plural referentsunless the context clearly dictates otherwise. Thus, for example, theterm “a lumen” is intended to mean a single lumen or a combination oflumens. Furthermore, the words “proximal” and “distal” refer todirection closer to and away from, respectively, an operator (e.g.,surgeon, physician, nurse, technician, etc.) who would insert themedical device into the patient, with the tip-end (i.e., distal end) ofthe device inserted first inside a patient's body. Thus, for example,the end first inserted inside a patient's body would be the distal endof the medical device, while the end outside of or inserted later into apatient's body would be the proximal end of the medical device.Additionally, the terms “first,” “second,” “third,” and so on, used todescribe similarly identified elements are for purposes of clarity only,and are not meant to imply a priority or that such numerical identifiermust be associated with that particular element in the claims.

FIGS. 1 and 2 are schematic illustrations of a vascular medical device100 according to an embodiment in a first configuration and a secondconfiguration, respectively. The medical device is configured to promotehealing of an aneurysm. More specifically, at least a portion of themedical device is configured to occupy at least a portion of the volumedefined by a sac of the aneurysm and, in some embodiments, at least aportion of the medical device is configured to promote endothelial cellattachment over a neck of the aneurysm. Once endothelialization over theaneurysm neck is complete, blood flow into the aneurysm sac from aparent blood vessel (i.e., the vessel on which the aneurysm formed) isprevented.

The medical device 100 can include an insertion portion 102 and anexpandable implant 110. The insertion portion 102 is coupled to theexpandable implant 110, such as, for example, at a proximal portion 112of the expandable implant 110. In some embodiments, the insertionportion 102 is removably coupled to the expandable implant 110. In thismanner, the insertion portion 102 can be separated from the expandableimplant 110 following delivery of the expandable implant to the aneurysmand removed from a patient's vasculature. The insertion portion 102 canbe, for example, a guide wire or a distal end portion of a wire. Themedical device 100 can be used with a cannula or catheter 104 (shown indashed lines in FIGS. 1 and 2) to, for example, deliver the expandableimplant 110 to the aneurysm.

The expandable implant 110 is configured to be deployed in the aneurysm(e.g., in a sac of an aneurysm). The expandable implant 110 has a firstportion 120 and a second portion 130. As shown in FIG. 1, the expandableimplant 110 has a first configuration in which the first portion 120 andthe second portion 130 are substantially linearly aligned. In its firstconfiguration, the expandable implant 110 is configured for insertionthrough a blood vessel. The expandable implant 110 is also configuredfor insertion through a neck of the aneurysm when in its firstconfiguration.

The expandable implant 110 is movable between its first configurationand a second configuration in which the second portion 130 at leastpartially overlaps the first portion 120, as shown in FIG. 2. Forexample, the second portion 130 can be configured to bend, curve and/ortwist in multiple turns such that multiple segments of the first portion120 and the second portion 130 are overlapped. Additionally, at leastone of the first portion 120 and the second portion 130 can beconfigured to bend or curve in multiple turns such that the respectivefirst or second portion is overlapped with itself. In some embodiments,the expandable implant 110 can be understood to have multiple firstportions and multiple second portions. In other words, the expandableimplant can continually overlap itself in its deployed configuration tooccupy all or substantially all of the volume of the aneurysm.

In its second configuration, the expandable implant 110 is configured tooccupy at least a portion of the volume defined by the sac of theaneurysm. In some embodiments, when the expandable implant 110 is in itssecond configuration, at least a portion of the expandable implant isconfigured to be positioned over the neck of the aneurysm. For example,the portion of the expandable implant 110 at which the second portion130 overlaps the first portion 120 can be configured to be positionedover the neck of the aneurysm. As such, the portion of the expandableimplant 110 disposed over the aneurysm neck has an increased density(e.g., a dual density compared to the first portion 120 or the secondportion 130 individually), which helps to limit or prevent blood flowfrom entering the sac of the aneurysm. The portion of the expandableimplant 110 positioned over the aneurysm neck can be a scaffold forendothelial cell attachment at the aneurysm neck. For example, theportion of the expandable implant 110 positionable over the aneurysmneck can be porous, such as by including a porous mesh, as described inmore detail herein. In some embodiments, the first portion 120 and thesecond portion 130 of the expandable implant 110 are biased to thesecond configuration.

As noted above, in some embodiments, at least a portion of theexpandable implant 110 is porous. For example, in some embodiments, atleast a portion of the expandable implant 110 can include and/or beconstructed of a mesh (e.g., woven, braided, or laser-cut) material suchthat a wall or layer of the expandable implant 110 defines multipleopenings or interstices 118. More specifically, in some embodiments, atleast one of or both the first portion 120 and the second portion 130 ofthe expandable implant 110 can include the porous mesh. The porous meshcan have a first porosity when the expandable implant 110 is in itsfirst configuration and a second porosity when the expandable implant isin its second configuration. More specifically, in some embodiments, theporous mesh can have a greater porosity when the expandable implant 110is in its second configuration than when the expandable implant is inits first configuration. The porosity of the porous mesh can beincreased, for example, because one or more individual pores or openingsare larger when in the second configuration than in the firstconfiguration. For example, the porous mesh can be expanded in thesecond configuration, thereby increasing the space between filaments ofthe mesh (and thus the size of one or more openings of the mesh). Inother words, an overall volume of pore openings can be increased. Inanother example, the porosity of the porous mesh can be increasedbecause one or more openings that were closed off when the expandableimplant 110 was collapsed into its first configuration are reopened whenthe expandable implant is moved to its second configuration. In otherwords, a number of open pores can be increased.

In some embodiments, the first portion 120 and the second portion 130can have one of the same or different porosities. For example, the firstportion 120 can have a porosity greater than a porosity of the secondportion 130. in another example, the second portion 130 can have aporosity greater than the porosity of the first portion 120. In stillanother example, the first and second portions 120, 130 can havesubstantially equivalent porosities in the expanded configuration.

In some embodiments, at least one of the first portion 120 and thesecond portion 130 includes one, two, three, or more layers. Forexample, in some embodiments, the first portion 120 of the expandableimplant 110 includes a first layer (not shown in FIG. 1 or 2) of porousmesh and a second layer (not shown in FIG. 1 or 2) of porous mesh. Thefirst layer and the second layer can have the same or differentporosities. In some embodiments, the first layer is offset from thesecond layer. As such, the porosity of the first portion is determinedby the porosities of the first and second layers and the manner in whichthe first layer is offset from the second layer.

In some embodiments, at least a portion of the expandable implant 110,such as at least one of the first portion 120 or the second portion 130can include a shape-memory material, such as, for example, nitinol, andcan be preformed to assume a desired shape. Thus, in such an embodiment,the portion of the expandable implant 110 (e.g., the first portion 120and/or the second portion 130) can be biased into an expanded secondconfiguration and moved to a collapsed first configuration byrestraining or compressing the portion of the expandable implant.

In some embodiments, at least a portion of the expandable implant 110,such as at least one of the first portion 120 or the second portion 130can include an electropositive material, described in more detail below.

The expandable implant 110 when in the expanded configuration can have avariety of different shapes, sizes and configurations. For example, insome embodiments, when in the expanded configuration the expandableimplant 110 can be substantially spherical. In some embodiments, theexpandable implant 110 can be substantially helical. In someembodiments, the expandable implant 110 can be substantially circular,disc-shaped, or ring-shaped. In some embodiments, the expandable implant110 can be a custom-made shape based on a shape of a target aneurysmwithin a patient: for example, a shape modeled after the shape of thetarget aneurysm as detected by an imaging device. For example, an imageof the aneurysm shape can be acquired using an angiogram, and theexpandable implant 110 can be modeled after the shape of the aneurysmshown in the angiogram. In some embodiments, the expandable implant 110can include multiple portions having varying outer perimeters or outerdiameters. For example, in some embodiments, when in the expandedconfiguration the expandable implant 110 can include a first portionhaving a first outer perimeter, a second portion having a second outerperimeter and a third portion having a third outer perimeter. In such anembodiment, the second outer perimeter can be smaller than each of thefirst outer perimeter and the third outer perimeter.

In one example use of the medical device 100, a catheter 104 can beinserted into a blood vessel and directed to a desired treatment sitenear a vascular defect, such as the aneurysm. The expandable implant 110is inserted into an elongate lumen of the catheter 104 for delivery tothe treatment site. A distal portion of the catheter 104 is positionedadjacent the aneurysm within the blood vessel. The expandable implant110 is moved from a first position inside the catheter to a secondposition outside the catheter. When the expandable implant 110 is in itsfirst position, each of the first portion 120 and the second portion 130are in a first configuration. For example, in the first configuration,each of the first and second portions 120, 130 can be compressed orcollapsed within the lumen of the catheter 104 and are substantiallylinear in configuration.

The expandable implant 110 can be oriented with respect to an opening inthe vessel wall in fluid communication with the aneurysm such that theexpandable implant can enter a sac of the aneurysm when the expandableimplant 110 is moved to its second position. The expandable implant 110can be moved from its first position to its second position with theassistance of the insertion portion 102 such that the expandable implant110 is directed into and positioned within a sac of the aneurysm. Whenthe expandable implant 110 is in its second position, the first andsecond portions each have a second configuration. For example, in thesecond configuration, each of the first and second portions 120, 130 canbe expanded into a three-dimensional shape. The three-dimensional shapeof the first portion 120 in the second configuration can be similar toor different from the three-dimensional shape of the second portion 130.In the second configuration, the first portion 120 of the expandableimplant 110 substantially overlaps the second portion 130. In someembodiments, the second portion 130 is disposed in an interior regiondefined by the first portion when each of the first portion and thesecond portion are in their respective second configurations.

The first and second portions 120, 130 can be moved to their respectivesecond configurations concurrently or sequentially. For example, in someembodiments, the second portion 130 is moved to its second configurationbefore the first portion 120 is moved to its second configuration. Theexpandable implant 110 can assume a biased expandable configuration suchthat the walls of the expandable implant 110 contact at least a portionof the wall of the aneurysm and/or such that a portion of the expandableimplant is disposed over the neck of the aneurysm. The presence of theexpandable implant 110 over the neck of the aneurysm can substantiallyreduce and/or prevent further blood flow from the parent vessel into theaneurysm sac because the expandable implant can act as a physical flowdisruptor for blood flowing from the parent vessel and as a scaffold forendothelial cell attachment at the aneurysm neck to promoteendothelialization of the neck/vessel wall. The insertion portion 102can then be disconnected from a proximal end of the expandable implant110 and removed through the catheter 104.

FIGS. 3, 4, 5A, 5B and 5C illustrate a medical device according to anembodiment. The medical device 200 can include all or some of the samefeatures and functions as described above for medical device 100. Themedical device 200 includes an insertion portion 202 and an expandableimplant 210. The expandable implant 210 is removably coupled at itsproximal end to a distal end of the insertion portion 202.

The expandable implant 210 includes a first portion 220 and a secondportion 230. As shown in FIGS. 3 and 5A, the expandable implant 210 hasa first, or collapsed, configuration in which the first and secondportions 220, 230 are substantially linearly aligned. In this manner,the expandable implant 210 can be disposed within a lumen of a catheter204 for delivery through a blood vessel V to a treatment site, such asto an aneurysm A. In its first configuration, the expandable implant 210has a first width W₁, as shown in FIG. 2. As shown in FIGS. 4 and 5B-5C,the expandable implant 210 is moveable to a second, or expanded ordeployed, configuration. The insertion portion 202 is configured to movethe expandable implant 210 from the first configuration to the secondconfiguration. The insertion portion 202 can be disconnected from theexpandable implant 210 when the expandable implant 210 is in its secondconfiguration.

In its second configuration, the expandable implant 210 is configured tooccupy at least a portion of the volume defined by a sac of the aneurysmA. As such, the expandable implant 210 has a second width W₂ in thesecond, expanded, configuration greater than its first width W₁. Forexample, the expandable implant 210 can be substantially narrow andelongate in its first configuration and can assume a three-dimensionalshape in its second configuration. In the embodiments illustrated inFIGS. 3-5C, the expandable implant 210 has a substantially sphericalshape in its second configuration. The expandable implant 210 can becompliant such that its three-dimensional shape can accommodate anyirregularities in the shape of the aneurysm. In the secondconfiguration, the second portion 230 of the expandable implant 210 atleast partially overlaps the first portion 220. At least a portion ofthe expandable implant 210 is configured to be positioned over a neck Nof the aneurysm A when the expandable implant is in its secondconfiguration within the sac of aneurysm A. The expandable implant 210is configured to facilitate endothelial cell attachment at the neck N ofthe aneurysm A, as described in more detail herein.

In the embodiment illustrated in FIG. 3, the first portion (or member)220 is a first ribbon-like strand and the second portion (or member) 230is a second ribbon-like strand discrete from the first portion. In otherembodiments, an expandable implant can include a first portion and asecond portion from a single ribbon-like strand (e.g., integrally ormonolithically constructed), instead of discrete portions. A first end222 of the first portion 220 is coupled to a first end 232 of the secondportion 230. Any suitable mechanism for coupling the first end 222 ofthe first portion 220 to the first end 232 of the second portion 230 canbe used, such as an adhesive, a mechanical coupler, a weld, or the like,or any combination of the foregoing. For example, the first ends 222,232 can be coupled by a band 240. The band 240 can also be configured tohelp couple the insertion portion 202 to the expandable implant 210. Theband 240 can be or can include, for example, a radiopaque marker.

A second end 224 of the first portion 220 and a second end 234 of thesecond portion 230 each have a radiopaque marker 242, 244, respectively,coupled thereto. The radiopaque markers 242, 244 are configured tofacilitate imaging of the expandable implant 210 during delivery to thetreatment site and/or subsequent to implantation. The markers 242, 244are configured to be wholly disposed within the sac of the aneurysm Awhen the expandable implant 210 is in its second configuration. As such,the markers 242, 244 will not puncture the wall of the aneurysm A or thevessel V, and the markers 242, 244 will not interfere with endothelialcell attachment at the aneurysm neck. This is also beneficial because ifthe markers 242, 244 were positioned at or proximate to the neck of theaneurysm, blood from a parent blood vessel could have a tendency to clotaround the marker.

When the expandable member 210 is moved between its first configurationand its second configuration, at least one of the first portion 220 andthe second portion 230 is also moveable between a first configurationand a second configuration. The first portion or member 220 has a first,collapsed, configuration in which the first portion 220 is substantiallyelongate and has a first width. The first portion 220 has a second,expanded, configuration, in which the first portion 220 has a secondwidth greater than the first width. For example, the first portion 220can be moveable from a substantially linear, elongate collapsedconfiguration to a multi-dimensional (e.g., three-dimensional) shape inthe expanded or deployed configuration. As shown in FIGS. 4 and 5C, thefirst portion 220 can have a three-dimensional shape in the expandedconfiguration that lends an overall spherical shape to the expandableimplant 210. The first portion 220 can be biased to its second,expanded, configuration.

The first portion or member 220 is porous and, for example, can includeor be constructed of a porous mesh. The porous mesh can be formed usingfilaments that are woven or braided together in a manner that openingsor interstices are present between portions of the filaments at leastwhen the expandable implant 210 is in its second configuration. Forexample, the porous mesh can include a plurality of braided wires.Suitable mesh material is described in more detail herein. The porousmesh can have a first porosity when the first portion 220 is in thefirst configuration and a second porosity when the first portion 220 isin the second configuration. For example, when the first portion 220 ismoved from its first, collapsed, configuration to its second, expanded,configuration, the mesh can be expanded such that the size of theopenings of the mesh is increased, thus increasing the porosity of themesh. The porous mesh is configured to act as a scaffold that promotesclot formation and endothelium cell attachment when the mesh is disposedwithin the aneurysm A. Specifically, endothelial cells will migrate tothe openings of the mesh.

The first portion 220 of the expandable implant 210 includes a firstlayer of porous mesh and a second layer of porous mesh. In this manner,the density of the first portion 220 is greater than the density ofeither the first or second layers individually. Such a dual-densitystructure can help to limit or prevent blood flow into the aneurysm A,for example when the first and second layers of the first portion 220are disposed over the neck N of the aneurysm A. The first layer ofporous mesh and the second layer of porous mesh can have the sameporosities, or different porosities. The first layer of porous mesh canbe offset from the second layer of porous mesh. In this manner, theoverall porosity of the first portion 220 is greater than the porosityof either the first or second layers individually. The first and secondlayers of porous mesh can be coupled together in any suitable manner.For example, the first portion 220 can be formed using an elongatetubular mesh having an elongate lumen therethrough. In such anembodiment, the elongate mesh can be flattened from a tubular structureto a ribbon-like structure such that a first side, or layer, of the meshis disposed on or proximate to a second side, or layer, of the mesh,thus forming a dual density, or dual-layered, mesh structure.

The second portion, or member, 230 of the expandable implant 210 can beconfigured the same as or similar to, and can be used in the same orsimilar manner, as the first portion 220. When the expandable member 210is moved between its first configuration and its second configuration,the second portion 230 is also moveable between a first, collapsed,configuration in which the second portion is substantially elongate andhas a third width, and a second, expanded, configuration, in which thesecond member has a fourth width greater than the third width. Forexample, the second portion 230 can be moveable from a substantiallylinear, elongate collapsed configuration to a multi-dimensional (e.g.,three-dimensional) shape in the expanded configuration. As shown inFIGS. 4 and 5C, the second portion 230 can have a three-dimensionalshape in the expanded configuration that lends an overall sphericalshape to the expandable implant 210. The second portion 230 can bebiased to its second, expanded, configuration.

The second portion 230 is porous and can include or be constructed of aporous mesh. The porous mesh can be configured the same as or similarto, and can be used in the same or similar manner, as the porous meshdescribed above with respect to the first portion 220 of the expandableimplant 210. For example, the porous mesh can include a weave or braidof filaments that is porous at least when the expandable implant 210 isin its second configuration. Additionally, the porous mesh of the secondportion 230 can have a first porosity when the second portion 230 is inthe first configuration and a second porosity when the second portion230 is in the second configuration. In some embodiments, the secondportion 230 of the expandable implant 210 includes a first layer ofporous mesh and a second layer of porous mesh, which can be of the sameor different porosities. In this manner, the total density of the secondportion 230 is greater than the density of either the first or secondlayers individually. The first layer of porous mesh can be offset fromthe second layer of porous mesh such that the overall porosity of thesecond portion 230 is greater than the porosity of either the first orsecond layers individually. Similarly as described above with respect tothe first portion 220, the first and second layers of porous mesh of thesecond portion 230 can be formed from a monolithically constructedelongate tubular mesh that is flattened into a ribbon-like structure.

The first portion 220 and the second portion 230 of the expandableimplant 210 can be the same or different sizes. For example, as shown inFIG. 5A, the first portion 220 can have a length in its first,collapsed, configuration, that is less than a length of the secondportion 230 in its first, collapsed, configuration. In this manner, themarkers 242, 244 will be sequentially introduced through the neck N ofthe aneurysm A, which permits the expandable implant 210 to beintroduced through a narrower neck N. In another example, the firstportion 220 and the second portion 230 can have the same or differentwidths. In some embodiments, for example, the first width of the firstportion 220 in its first configuration is wider than the third width ofthe second portion 230 in its first configuration. The second width ofthe first portion 220 in its second configuration can also be wider thanthe fourth width of the second portion 230 in its second configuration.In another example, the fourth, expanded, width of the second portion230 can be greater than the second, expanded, width of the first portion220. In some embodiments, the porous mesh of the first portion 220 canhave a multi-dimensional shape with a first width when the expandableimplant 210 is in its second configuration, and the porous mesh of thesecond portion 230 can have a multi-dimensional shape with a secondwidth less than the first width when the expandable implant is in itssecond configuration.

In some embodiments, for example, the first portion 220 (or the porousmesh of the first portion) can have a width of about 8 mm when theexpandable implant is expanded in its second configuration, and thesecond portion 230 (or the porous mesh of the second portion) can have awidth of about 9.5 mm when the expandable implant is expanded in itssecond configuration. As such, in an embodiment in which the firstportion 220 has a smaller overall size in the expanded configurationthan the second portion 230, the first portion 220 can be configured tobe disposed within an open interior region formed by the second portion230 in its second configuration.

In some embodiments, a variation of medical device 200 is contemplated.For example, in such an embodiment, the first portion of the expandableimplant can include a first tubular mesh that defines a lumentherethrough, and the second portion of the expandable implant caninclude a second tubular mesh disposed within the lumen of the firsttubular mesh. The first and second tubular mesh structures can be formedinto a substantially ribbon-like strand. As such, the expandable implanthas a four-layer density. The expandable implant can include additionalribbon-like strands in addition to the strand formed by the first andsecond portions. For example, the expandable implant can include one,two, three, four, five, six, seven, eight, or nine strands, with each ofthe strands having a desired number of layers (e.g., two, four, or morelayers). As such, an expandable implant can be formed that has a desiredamount of density. As noted above, a highly dense structure helps toprevent blood flow from the parent blood vessel into the aneurysm. Eachlayer or portion of the expandable implant can have the same ordifferent density as the other layers or portions. Furthermore, eachlayer or portion of the expandable implant can have the same ordifferent porosity as the other layers or portions.

FIG. 6 illustrates a portion of another embodiment of a medical device.The medical device 300 can include the same or similar features andfunctions as described above for previous embodiments. For example, themedical device 300 includes an expandable implant 310 and an insertionportion or member (not shown in FIG. 6). The expandable implant 310 isshown in an expanded configuration and can be moved between a compressedor collapsed configuration in which the expandable implant issubstantially elongate and the expanded configuration in the same orsimilar manner as described above for expandable implant 210. In theexpanded configuration, a first portion 320 of the expandable implant310 is overlapped by a second portion 330 of the expandable implant.Additionally, at least a portion of the first portion 320 is disposedwithin an open interior region 336 defined by the second portion 330when the expandable implant 310 is in its expanded configuration.

The expandable implant 310 includes a ribbon-like strand of porous mesh.At least a portion of the porous mesh is configured to be positionedover a neck of an aneurysm when the expandable implant 310 is in theexpanded configuration. The porous mesh is configured to bend, curve,and/or twist at multiple turns into a substantially spherical shape whenthe expandable implant 310 is in the expanded configuration. The porousmesh can be a ribbon-like structure that is wider than the porous meshof expandable implant 210. In this manner, the porous mesh of expandableimplant 310 can be a shorter length than that of expandable implant 210and still provide a similar amount of coverage within the aneurysm (andover the neck of the aneurysm) as expandable implant 210. The porousmesh can include one, two, or more layers depending on the desireddensity and porosity of the expandable implant 310. In some embodiments,a first radiopaque marker 342 is coupled to a first end 312 of theexpandable implant 310 and a second radiopaque marker 344 is coupled toa second end 314 of the expandable implant. The expandable implant 310is configured to be wholly disposed within the aneurysm such that theradiopaque markers 342, 344 are wholly disposed within the aneurysm sacand the porous mesh is disposed over the neck of the aneurysm. In someembodiments, the radiopaque markers are configured to be positioned at aside of the aneurysm (i.e., disposed away from the neck of theaneurysm).

FIG. 7 illustrates another embodiment of a medical device. The medicaldevice 400 can include the same or similar features and functions asdescribed above for previous embodiments. For example, the medicaldevice 400 includes an expandable implant 410 and an insertion portionor member 402. The expandable implant 410 is sized to occupy the sac ofan aneurysm, and the insertion member 402 is configured to facilitatedelivery of the expandable implant into the sac of the aneurysm. Theexpandable implant 410 is shown in an expanded configuration and can bemoved between a compressed or collapsed configuration and the expandedconfiguration in the same or similar manner as described above forprevious embodiments.

The expandable implant 410 includes at least one ribbon-like strand ofporous mesh configured to be expanded within the aneurysm as a 360degree spiral or ring-shaped structure. In the expanded configuration, afirst portion 420 of the expandable implant 410 is overlapped by asecond portion (not shown in FIG. 7) of the expandable implant, which isoverlapped by a third portion 450 of the expandable implant. In thismanner, at least a portion of the expandable implant 410 includes two,three, four, or more layers of implant material (e.g., porous mesh, asdescribed above in previous embodiments), which can be positioned overthe neck of the aneurysm from within the aneurysm to function as a denseflow disruptor. In some embodiments, a radiopaque marker 442 is coupledto the expandable implant 410.

FIG. 8 illustrates another embodiment of a medical device. The medicaldevice 500 can include the same or similar features and functions asdescribed above for medical device 400. For example, the medical device500 includes an expandable implant 510 and an insertion portion ormember 502. The medical device 500 can be delivered to an aneurysm orother vascular defect using a microcatheter 504. The expandable implant510 is sized to occupy at least a portion of the volume defined by thesac of the aneurysm, and the insertion member 502 is configured tofacilitate delivery of the expandable implant into the sac of theaneurysm. The expandable implant 510 is shown in an expandedconfiguration and can be moved between a compressed or collapsedconfiguration and the expanded configuration in the same or similarmanner as described above for previous embodiments.

The expandable implant 510 includes a porous mesh configured to beexpanded within the aneurysm as a substantially circular or disc-shapedstructure, as shown in FIG. 8. In the expanded configuration, a firstend portion 512 of the expandable implant 510 is engaged with and/oroverlapped with a second end portion 514 of the expandable implant. Theexpandable implant 510 includes a first portion 520 having a firstdensity of porous mesh and a second portion 530 having a second, higher,density of porous mesh. More specifically, a weave or braid of theporous mesh has a higher density in the second portion 530 than in thefirst portion 520 of the expandable implant. The expandable implant 510is configured to be disposed within the aneurysm (or other vasculardefect) such that at least a portion of the second portion 530 isdisposed over the neck of the aneurysm, because the higher densitypromotes endothelial cell attachment to the expandable implant. Theexpandable implant 510 includes at least one radiopaque marker 542,which can be disposed on one of the first end portion 512 (as shown inFIG. 8) and/or the second end portion 514. When the expandable implant510 is disposed within the aneurysm in its expanded configuration suchthat the higher density second portion 530 is disposed over the neck ofthe aneurysm, the at least one radiopaque marker 542 is disposed withinthe sac of the aneurysm away from the neck of the aneurysm.

FIG. 9 illustrates another embodiment of a medical device. The medicaldevice 600 can include the same or similar features and functions asdescribed above for previous embodiments. For example, the medicaldevice 600 includes an expandable implant 610 and an insertion portionor member 602. The expandable implant 610 is sized to occupy at least aportion of a volume defined by the sac of the aneurysm, and theinsertion member 602 is configured to facilitate delivery of theexpandable implant into the sac of the aneurysm. The expandable implant610 is shown in an expanded configuration and can be moved between acompressed or collapsed configuration and the expanded configuration inthe same or similar manner as described above for previous embodiments.

The expandable implant 610 includes a ribbon-like strand of porous meshhaving at least two layers of mesh. The expandable implant 610 isconfigured to be expanded within the aneurysm as a substantially helicalor coil shaped structure, as shown in FIG. 9. The expandable implant 610can be disposed within the aneurysm (or other vascular defect) such thatat least a portion of the implant is disposed over the neck of theaneurysm to facilitate endothelial cell attachment at the neck. Theexpandable implant 610 includes at least one radiopaque marker 642,which can be disposed on an end of the expandable implant 610, as shownin FIG. 9. The insertion member 602 can be removably coupled to theexpandable implant at the radiopaque marker.

FIG. 10 illustrates another embodiment of a medical device. A medicaldevice 700 includes all the same or similar features and functions asdescribed above for medical device 600. For example, the medical device700 includes an expandable implant 710, an insertion portion or member702, and a radiopaque marker 742 coupled to an end of the expandableimplant. The expandable implant 710 includes a porous mesh formed of atubular or rounded braid structure. The rounded braid structure can lendmore softness to the expandable implant 710 than, for example, theflattened ribbon-like structure previously described.

FIG. 11 illustrates another embodiment of a medical device. The medicaldevice 800 can include the same or similar features and functions asdescribed above for previous embodiments. For example, the medicaldevice 800 includes an expandable implant 810 and an insertion portionor member 802. The medical device 800 can be delivered to an aneurysm orother vascular defect using a microcatheter 804. The expandable implant810 is sized to occupy at least a portion of the volume of the sac ofthe aneurysm, and the insertion member 802 is configured to facilitatedelivery of the expandable implant from the microcatheter 804 into thesac of the aneurysm. The expandable implant 810 is shown in an expandedconfiguration and can be moved between a compressed or collapsedconfiguration and the expanded configuration in the same or similarmanner as described above for previous embodiments.

The expandable implant 810 includes a first member 820 and a secondmember 830. The first and second members 820, 830 are coupled at a firstend 812 of the expandable implant 810 and a second end 814 of theexpandable implant. The first and second members 820, 830 are alsocoupled together at at least one middle portion of the expandableimplant 810 between the first end 812 and the second end 814. The firstand second members 820, 830 can be coupled, for example, usingradiopaque markers 842, 844, 846. Each site of coupling is configured tobe a folding point of the expandable implant 810 when the expandableimplant is delivered into the aneurysm and is expanded within theaneurysm to comply with the shape of the aneurysm. As such, theexpandable implant 810 can be more densely packed into the aneurysm, forexample, as compared to an implant that cannot bend or fold in responseto the shape of the aneurysm. At least one of the first member 820 andthe second member 830 of the expandable implant 810 includes a porousmesh formed of a tubular or rounded braid structure.

FIG. 12 illustrates another embodiment of a medical device. The medicaldevice 900 can include the same or similar features and functions asdescribed above for previous embodiments. For example, the medicaldevice 900 includes an expandable implant 910 and an insertion portionor member 902. The expandable implant 910 is sized to occupy the sac ofthe aneurysm, and the insertion member 902 is configured to facilitatedelivery of the expandable implant from a microcatheter (not shown inFIG. 12) into the sac of the aneurysm. The expandable implant 910 isshown in an expanded configuration and can be moved between a compressedor collapsed configuration and the expanded configuration in the same orsimilar manner as described above for previous embodiments.

The expandable implant 910 includes a series of expandable portions 920,922, 924, 926, 928 separated by a series of constricted portions 930,932, 934, 936. The expandable portions 920, 922, 924, 926, 928 can beconfigured to expand to any suitable multi-dimensional shape, including,for example, that resembling a sphere, a disc, a parabola, or the like.Additionally, each expandable portion 920, 922, 924, 926, 928 can havean expanded shape distinct from an expanded shape of another expandableportion.

When the expandable implant 910 is in its expanded configuration, asshown in FIG. 12, the expandable portions 920, 922, 924, 926, 928 aremore porous and less dense then the constricted portions 930, 932, 934,936. The density and/or porosity of each expandable portion 920, 922,924, 926, 928 can be varied from the other expandable portions 920, 922,924, 926, 928, and the density and/or porosity of each expandableportion 920, 922, 924, 926, 928 can be varied along a length and/orwidth of the respective expandable portion. For example, a firstexpandable portion 920 can be more dense and/or less porous proximate toa first constriction portion 930 and less dense and/or more porous at amiddle, wider portion of the first expandable portion 920. Additionally,the expandable portions 920, 922, 924, 926, 928 are each configured tohave a width greater than when the expandable implant 910 is in itscollapsed configuration, and the constricted portions 930, 932, 934, 936are each configured to have a width narrower than a width of theexpandable portions 920, 922, 924, 926, 928. As such, the expandableimplant 910 is configured to bend, curve, and/or fold at the constrictedportions 930, 932, 934, 936 to help comply with the shape of theaneurysm.

When the expandable implant 910 is in its expanded configuration, thefirst expandable portion 920 is configured to have a width greater thanthe width of the other expandable portions 922, 924, 926, 928. The firstexpandable portion 920 can be, as illustrated in FIG. 12, the mostproximal of the expandable portions 920, 922, 924, 926, 928. The firstexpandable portion 920 is configured to be positioned over a neck of theaneurysm when the expandable implant 910 is disposed within the aneurysmin its expanded configuration. In this manner, the first expandableportion 920 is configured to act as a flow disruptor at the neck of theaneurysm to help limit the flow of blood into the aneurysm from theparent blood vessel. The remaining, more distal, expandable portions922, 924, 926, 928 are configured to be packed into the aneurysm toembolize the aneurysm.

The expandable implant 910 includes a first radiopaque marker 942coupled to a first end 912 of the implant and a second radiopaque marker944 coupled to a second end 914 of the implant. The radiopaque markers942, 944 are configured to be wholly disposed within the sac of theaneurysm when the expandable implant 910 is disposed in the aneurysm inits expanded configuration.

FIG. 13 illustrates another embodiment of a medical device. The medicaldevice 1000 can include the same or similar features and functions asdescribed above for previous embodiments. For example, the medicaldevice 1000 includes an expandable implant 1010 and an insertion portionor member 1002. The expandable implant 1010 is sized to occupy the sacof the aneurysm, and the insertion member 1002 is configured tofacilitate delivery of the expandable implant into the sac of theaneurysm. The expandable implant 1010 is shown in an expandedconfiguration and can be moved between a compressed or collapsedconfiguration and the expanded configuration in the same or similarmanner as described above for previous embodiments.

The expandable implant 1010 includes a first porous member 1020 and asecond porous member 1030. The first porous member 1020 includes aporous mesh configured to have a multi-dimensional shape when theexpandable implant 1010 is in its expanded configuration. As such, thefirst porous member 1020 has a second width in the expandedconfiguration that is greater than a first width of the first porousmember in the collapsed configuration. The first porous member 1020 canbe configured to expand to any suitable multi-dimensional shape,including, for example, that resembling a parabola, as shown in FIG. 13,a sphere, a disc, or the like. The first porous member 1020 isconfigured to be positioned over a neck of the aneurysm when theexpandable member 1010 is disposed within the sac of the aneurysm todisrupt and/or stop the flow of blood into the aneurysm from the parentblood vessel. Additionally, the porous mesh of the first porous member1020 is configured to promote endothelial cell attachment at the neck ofthe aneurysm, which can help to heal over the neck of the aneurysm.

The second porous member 1030 includes a porous mesh configured to havea multi-dimensional shape when the expandable implant 1010 is in itsexpanded configuration. As such, the second porous member 1030 has afourth width in the expanded configuration greater than a third width ofthe second porous member in the collapsed configuration. The secondporous member 1030 can be configured to expand to any suitablemulti-dimensional shape, including, for example, that resembling a tube,as shown in FIG. 13, a sphere, a disc, a parabola, or the like. In theembodiment illustrated in FIG. 13, the second width of the first porousmember 1020 is greater than the fourth width of the second porous member1030. The second porous member 1030 is configured to be disposed withinthe sac of the aneurysm such that the first porous member 1020 isdisposed between the second porous member 1030 and the neck of theaneurysm. The second porous member 1030 is configured to be packed intothe aneurysm to embolize the aneurysm.

A radiopaque marker 1044 is disposed between the first porous member1020 and the second porous member 1030, and can be used to couple thefirst and second porous members. The expandable implant 1010 isconfigured to bend, curve, and/or fold at the radiopaque marker 1044,which can help the expandable implant 1010 comply with the shape of thesac of the aneurysm. Another radiopaque marker 1042 can be disposed on aproximate end of the expandable implant 1010, and can be used to couplethe insertion portion 1002 to the expandable implant. The radiopaquemarkers 1042, 1044 are configured to be wholly disposed within the sacof the aneurysm when the expandable implant 1010 is disposed in theaneurysm in its expanded configuration.

FIGS. 14-15 illustrate another embodiment of a medical device. Themedical device 1100 can include the same or similar features andfunctions as described above for previous embodiments. For example, themedical device 1100 includes a first porous member 1120, a second porousmember 1130, and an insertion portion or member 1102 removably couplableto the first and second porous members 1120, 1130.

The first porous member 1120 has a first end 1122 and a second end 1124.As shown in FIG. 14, the first porous member 1120 has a collapsedconfiguration for insertion through a blood vessel. In its collapsedconfiguration, the first porous member 1120 is substantially elongatewith a first length. As shown in FIG. 15, the first porous member 1120has an expanded configuration for occupying a sac of an aneurysm. Whenthe first porous member 1120 is in its expanded configuration, it has athree-dimensional shape and defines an open interior region 1126. Thefirst porous member 1120 can have any suitable three-dimensional shape.For example, the first porous member 1120 can be configured to curveinto a substantially spherical shape, as shown in FIG. 15. Additionally,in its expanded configuration, the first porous member 1120 includes afirst segment configured to overlap with a second segment, which can besimilar in many respects as described above with respect to expandableimplants 210 and 310, for example. For example, the first porous member1120 can include a mesh having a first segment configured to overlapwith a second segment of the porous mesh to form a higher densityportion of the first porous member 1120.

The second porous member 1130 has a first end 1132 and a second end1134. The second porous member 1130 has a collapsed, first,configuration (not shown in FIG. 14 or 15) for insertion through a bloodvessel. In its collapsed configuration, the second porous member 1130 issubstantially elongate with a second length less than the first lengthof the first porous member, and is configured to occupy a first volume.As shown in FIGS. 14 and 15, the second porous member 1130 has anexpanded, second, configuration for occupying at least a portion of thevolume of the sac of the aneurysm. When the second porous member 1130 isin its expanded configuration, it has a three-dimensional shape and isconfigured to occupy a second volume greater than the first volume. Thesecond porous member 1130 can have any suitable three-dimensional shape.For example, the second porous member 1130 can be configured to expandinto a substantially ball (e.g., spherical, round, oblong, or the like)shape, as shown in FIGS. 14 and 15. In the expanded configuration, thesecond porous member 1130 can have a porosity the same as, or differentthan, a porosity of the first porous member 1120. The second porousmember 1130 is configured to be disposed in the interior region 1126 ofthe first porous member 1120 when each of the first porous member andthe second porous member are in the deployed or expanded configurations.

In the embodiment illustrated in FIGS. 14 and 15, the second porousmember 1130 is coupled to the first porous member 1120. Specifically,the first end 1122 of the first porous member 1120 is coupled to thefirst end 1132 of the second porous member 1130. At least one of thefirst porous member 1120 and the second porous member 1130 includes aradiopaque marker. As shown in FIG. 14, a first radiopaque marker 1142can be disposed on the first ends 1122, 1132 of the first and secondporous members 1120, 1130 to couple the first and second porous memberstogether. A second radiopaque marker 1144 can be disposed on the secondend 1134 of the second porous member 1130. When the first and secondporous members 1120, 1130 are in their respective expandedconfigurations, the second radiopaque marker 1144 is disposed within theinterior region defined by the first porous member 1120.

In use, the first and second porous members 1120, 1130, and the firstand second radiopaque markers 1142, 1194, are wholly disposed within theaneurysm. The second porous member 1130 can be inserted into theaneurysm first and assume its expanded configuration therein. The firstporous member 1120 can then be inserted into the aneurysm such that thefirst porous member curves, coils, or otherwise wraps around the secondporous member 1130 as the first porous member moves to its expandedconfiguration. The first porous member 1120 is configured to be disposedwithin the aneurysm such that a portion of the first porous member isdisposed over the neck of the aneurysm. For example, the higher densityportion of the first porous member 1120 at which the first segmentoverlaps the second segment can be positioned over the neck of theaneurysm to promote endothelial cell attachment at the aneurysm neck.The second porous member 1130 can help to embolize the aneurysm byproviding additional porous mesh within the sac of the aneurysm for cellattachment and/or clot formation. As such, the second porous memberoccupies a portion of the volume of the sac of the aneurysm such thatblood flow through the aneurysm is further inhibited.

Although the medical device 1100 includes discrete first and secondporous members 1120, 1130, respectively, in other embodiments, the firstand second porous members can be differently constructed. For example,referring to FIG. 16, an embodiment of a medical device 1200 isillustrated. The medical device 1200 can include the same or similarfeatures and functions as described above for medical device 1100, orother previous embodiments. For example, the medical device 1200includes a first porous member 1220, a second porous member 1230, and aninsertion portion or member (not shown in FIG. 16) removably couplableto the first and second porous members. Each of the first porous member1220 and the second porous member 1230 can be similar in form andfunction as the first porous member 1120 and the second porous member1130, respectively, described above.

In the embodiment illustrated in FIG. 16, however, the second porousmember 1230 is monolithically constructed with the first porous member1220. It should be noted that in FIG. 16, the first and second porousmembers 1220, 1230, are shown in an expanded configuration but thesecond porous member 1230 is shown spaced apart from the first porousmember 1220 for illustration purposes only. In use, in their respectivedeployed or expanded configurations, the second porous member 1230 isdisposed within an interior region 1226 defined by the first porousmember 1220 in a similar manner as that illustrated in FIG. 15 withrespect to medical device 1100. Additionally, the medical device 1200includes two radiopaque markers 1242, 1244. A first radiopaque marker1242 is disposed at an end of a porous mesh of the first porous member1220, and the second radiopaque marker 1244 is disposed at an opposingend of porous mesh of the second porous member 1230.

In some embodiments, a medical device includes an expandable implantthat has a substantially continuous outer surface when in an expandedconfiguration. Referring to FIGS. 17A and 17B, a portion of a medicaldevice 1300 according to an embodiment is illustrated in a collapsedconfiguration and an expanded configuration, respectively. The medicaldevice 1300 can include the same or similar features and functions asdescribed herein for other embodiments. For example, the medical device1300 can include an expandable implant 1310 configured to move from thecollapsed configuration (e.g., for delivery through a blood vessel) tothe expanded configuration (e.g., for deployment within an aneurysm).The expandable implant 1310 includes at least a first portion 1320 and asecond portion 1330, and can include additional portions 1340, 1350,1360. When the expandable implant 1310 is in its expanded configuration,the expandable implant 1310 has a three-dimensional shape (e.g., asubstantially spherical shape) with a substantially continuous outersurface such that edges of at least two of the portions 1320, 1330,1340, 1350, 1360 overlap. For example, edges of the first portion 1320and the second portion 1330 can overlap, as shown in FIG. 17B. In otherwords, the expandable implant 1310 moves into the expanded configurationsuch that few or no openings or spaces remain between edges of theportions 1320, 1330, 1340, 1350, 1360 of the expandable implant 1310.

FIG. 18 is a flowchart illustrating a method 80 of using a medicaldevice to disrupt blood flow into an aneurysm and to promote healing ofthe aneurysm, as described herein, according to an embodiment. Themethod 80 includes at 82, positioning a catheter adjacent to an aneurysmof a blood vessel. For example, a distal portion of the catheter can bepositioned adjacent an opening from the blood vessel into the aneurysm.The catheter defines an elongate lumen, which can be configured toreceive at least a portion of the medical device for delivery to theaneurysm.

At 84, optionally, an expandable implant of the medical device isinserted into the catheter. The expandable implant includes a firstportion and a second portion, each of which has a first (e.g., insertionor collapsed) configuration and a second (e.g., deployed or expanded)configuration. In the second configuration, the first portionsubstantially overlaps the second portion. Each of the first portion andthe second portion also include a porous mesh. The porous mesh has afirst porosity when in the first configuration and a second porositywhen in the second configuration. The second porosity can be, forexample, greater than the first porosity. The expandable implant can bebiased in its second configuration before being inserted into thecatheter. The expandable implant is in its first configuration when theexpandable implant is disposed in the lumen of the catheter. Theexpandable implant can be inserted into the catheter after the catheteris positioned within the blood vessel, before the catheter is introducedinto the blood vessel, or any time therebetween.

At 86, the expandable implant is optionally oriented to the opening inthe vessel wall in fluid communication with the aneurysm. In thismanner, the expandable implant is oriented to enter a sac of theaneurysm when the expandable implant is moved out of the catheter, asdescribed in more detail herein.

At 88, the expandable implant is moved from a first position inside thecatheter to a second position outside the catheter. For example, theexpandable implant can be moved from a first position inside the lumenof the catheter to a second position in at least one of the blood vesselor the aneurysm outside of the catheter. As noted above, the expandableimplant is in its first configuration when in its first position insidethe catheter. The expandable implant is moved to its secondconfiguration when in its second position outside of the constraint ofthe catheter. The second portion of the expandable implant can be movedto its second configuration before the first portion is moved to itssecond configuration. In their respective second configurations, thesecond portion can be disposed in an interior region defined by thefirst portion. For example, the second portion can be moved to itssecond configuration in which it has a multi-dimensional expanded shape,and then the first portion can be moved to its second configuration inwhich it curves into a multi-dimensional expanded shape around thesecond portion.

The medical device can include an insertion portion configured to movethe expandable implant from its first position to its second position.The insertion portion can be, for example, a wire coupled to one of thefirst portion or the second portion of the expandable implant. At 90,the insertion portion is optionally disconnected from the expandableimplant. For example, the insertion portion can be disconnected from aproximal end of the expandable implant, such as after the expandableimplant has been inserted into the aneurysm. At 92, the insertionportion is optionally removed from the blood vessel through thecatheter.

After the expandable implant is disposed within the aneurysm, or othertarget vascular defect, the portion of a patient's body including theaneurysm can be imaged (e.g., using X-ray or other suitable imagingtechniques) to determine whether the expandable implant is properlypositioned within the aneurysm. For example, the expandable implant caninclude one or more radiopaque markers that are visible using X-ray. Inanother example, the patient can be injected intravenously with aradiopaque dye at a desired time following implantation of theexpandable implant to determine the success of endothelial cellattachment and/or healing over of the neck of the aneurysm following theprocedure. If radiopaque dye is visible within the parent blood vesseladjacent the aneurysm, but not within the aneurysm itself, theexpandable implant has operated to successfully prevent further bloodflow into the aneurysm. If radiopaque dye is visible within theaneurysm, blood flow from the parent blood vessel has not beencompletely prevented and additional treatment options may be consideredby the health care practitioner.

FIG. 19A illustrates a portion of another embodiment of a medicaldevice. The medical device 1400 can include the same or similar featuresand functions as described above for previous embodiments. For example,the medical device 1400 includes an expandable implant 1410 and aninsertion portion or member (not shown in FIG. 19A). The expandableimplant 1410 is shown in an expanded configuration and can be movedbetween a compressed or collapsed configuration in which the expandableimplant 1410 is substantially elongate and the expanded configuration inthe same or similar manner as described above for previous embodiments.

The expandable implant 1410 includes a ribbon-like strand of porous meshand includes petal-like portions or sections 1425 and 1427 along itslength. At least a portion of the porous mesh is configured to bepositioned over a neck of an aneurysm when the expandable implant 1410is in the expanded configuration. The expandable implant 1410 includes afirst portion 1420 that includes the petal-like portions 1427 and asecond portion 1430 that includes the petal-like portions 1427. Thepetal-like portions 1425 of the second portion 1430 are larger than thepetal-like portions 1427 of the first portion 1420 such that when theexpandable implant 1410 is moved to its expanded configuration, thepetal-like portions 1425 of the second portion at least partiallyoverlap the petal-like portions 1427 of the first portion 1420. Duringdeployment of the expandable implant 1410 (e.g., when moved from itscollapsed configuration to its expanded configuration) the petal-likeportions 1425 of the second portion 1430 will deploy first, and then thepetal-like portions 1427 of the first portion 1420 will deploy at leastpartially within an interior region defined by the second portion 1430.The petal-like portions 1425 of the second portion 1430 can be sized andconfigured to be disposed at a neck of an aneurysm when the expandableimplant 1410 is in the expanded configuration. The petal-like portions1427 of the first portion 1420 can be formed in a smaller diameterfixture than the petal-like portions 1425, and can be sized andconfigured to substantially fill the aneurysm and to hold the secondportion 1430 in place at the neck of the aneurysm when the expandableimplant 1410 is in the expanded configuration. For example, thepetal-like portions 1427 of the first portion 1420 can have a diameterof about 2 mm-12 mm, and the petal-like portions 1425 of the secondportion 1430 can have a corresponding diameter of about 1 mm larger thanthe petal-like portions 1427 of the first portion 1420. For example, thepetal-like portions 1425 of the second portion 1430 can be about 3 mm-13mm. FIG. 19B is a schematic illustration of the expandable implant 1410in its expanded configuration showing the positional relationship of thefirst portion 1420 to the second portion 1430.

As described for previous embodiments, a first radiopaque marker 1442 iscoupled to a first end of the expandable implant 1410 and a secondradiopaque marker (not shown) is coupled to a second end of theexpandable implant 1410. The expandable implant 1410 is configured to bewholly disposed within the aneurysm such that the radiopaque markers arewholly disposed within the aneurysm sac and the porous mesh is disposedover the neck of the aneurysm. In some embodiments, the radiopaquemarkers are configured to be positioned at a side of the aneurysm (i.e.,disposed away from the neck of the aneurysm).

FIG. 20 illustrates a portion of another embodiment of a medical device.The medical device 1500 can include the same or similar features andfunctions as described above for previous embodiments. For example, themedical device 1500 includes an expandable implant 1510 and an insertionportion or member (not shown in FIG. 20). The expandable implant 1510 isshown in an expanded configuration and can be moved between a compressedor collapsed configuration in which the expandable implant 1510 issubstantially elongate and the expanded configuration in the same orsimilar manner as described above for previous embodiments.

As with the previous embodiment, the expandable implant 1510 includes aribbon-like strand of porous mesh. At least a portion of the porous meshis configured to be positioned over a neck of an aneurysm and at leastanother portion of the porous mesh substantially fills the volume of theaneurysm when the expandable implant 1510 is in the expandedconfiguration. The expandable implant 1510 includes a first portion 1520and a second portion 1530. In this embodiment, each of the first portion1520 and the second portion 1530 form a sphere when the expandableimplant 1510 is in its expanded configuration. One of the first portion1520 or the second portion 1530 can be configured to be disposed at aneck of the aneurysm and the other of the first portion 1520 or thesecond portion 1530 can substantially fill the volume of the aneurysm.For example, in this embodiment, the first portion 1520 can beconfigured to be deployed at the dome of an aneurysm and serve as ananchor for the second portion 1530 and the second portion 1530 can bedisposed across the neck of the aneurysm when the expandable implant1510 is in the expanded configuration. The expandable implant 1510 canalso include radiopaque markers (not shown) as described above forprevious embodiments.

FIGS. 21 and 22 illustrate another embodiment of a medical device. Themedical device 1600 can include the same or similar features andfunctions as described above for previous embodiments. For example, themedical device 1600 includes an expandable implant 1610 and an insertionportion or member (not shown). The expandable implant 1610 is shown inan expanded configuration and can be moved between a compressed orcollapsed configuration as shown in FIG. 22 and the expandedconfiguration as shown in FIG. 21 in the same or similar manner asdescribed above for previous embodiments.

As with the previous embodiment, the expandable implant 1610 includes aribbon-like strand of porous mesh that includes a first portion 1620 inthe form of a disc-shaped structure and a second portion 1630 thatincludes petal-like portions or sections along its length (similar tothe embodiment of FIG. 19A). The disc or spherical shaped structure ofthe first portion 1620 can be disposed at various locations along thelength (e.g., middle, end, etc.) of the expandable implant 1610. Atleast a portion of the porous mesh is configured to be positioned over aneck of an aneurysm when the expandable implant 1610 is in the expandedconfiguration. In this embodiment, when the expandable implant 1610 isin the expanded configuration, the petal-like portions of the secondportion 1630 at least partially overlap the disc-shaped structure of thefirst portion 1620. For example, when the expandable implant 1610 is inits expanded configuration, the petal-like portions of the secondportion 1630 can define a diameter greater than a diameter defined bythe disc or spherical shaped structure of the first portion 1620. Theexpandable implant 1610 can also include a first radiopaque marker 1642coupled to a first end 1612 of the expandable implant 1610 and a secondradiopaque marker (not shown) coupled to a second end (not shown) of theexpandable implant 1610. The expandable implant 1610 can also include aconnector 1652 coupled to a first end 1612 of the expandable implant1610.

When the expandable implant 1610 is in its expanded configuration, theexpandable implant 1610 has a three-dimensional shape (e.g., asubstantially spherical shape) with a substantially continuous outersurface such that edges of at least two of the petal-like portions 1625overlap each other (in a similar manner as the embodiment of FIGS. 17Aand 17B), and at least partially overlap the disc-shaped portion 1620.The expandable implant 1610 can move into the expanded configurationsuch that few or no openings or spaces remain between petal-likeportions 1625 of the expandable implant 1610.

FIGS. 23 and 24 illustrate a portion of another embodiment of a medicaldevice. The medical device 1800 can include the same or similar featuresand functions as described above for previous embodiments. For example,the medical device 1800 includes an expandable implant 1810 and aninsertion portion or member (not shown in FIGS. 23 and 24). Theexpandable implant 1810 can be moved between a collapsed configurationas shown in FIG. 23 and an expanded configuration as shown in FIG. 24.

Similar to the embodiment of FIG. 19A, the expandable implant 1810includes a ribbon-like strand of porous mesh that includes petal-likeportions or sections 1825 along its length. At least a portion of theporous mesh is configured to be positioned over a neck of an aneurysmwhen the expandable implant 1810 is in the expanded configuration. Whenthe expandable implant 1810 is in its expanded configuration, theexpandable implant 1810 has a three-dimensional shape (e.g., asubstantially spherical shape) with a substantially continuous outersurface such that edges of at least two of the petal-like portions 1825overlap each other as shown in FIG. 24.

In this embodiment, when the implantable implant 1810 is formed, theribbon-like strand of porous mesh is wrapped around the forming fixturein a multi-directional fashion. For example, a portion of the mesh canbe wrapped in a continuous manner around the fixture as indicated at Cin FIG. 23, and a portion of the mesh can be wrapped in an s-shapemanner as indicated at S in FIG. 23. With such forming, when theexpandable implant 1810 is moved to its expanded configuration, thepetal-like portions 1825 that have been formed by wrapping in acontinuous manner will follow each other (each petal-like portion 1825will cause the adjacent petal-like portion 1825 to collapse), and thepetal-like portions 1825 that have been formed in a s-shape manner willindividually self-deploy or collapse. The multi-directional heat formingof the expandable implant 1810 can allow the expandable implant 1810 todeploy fragmented within an aneurysm.

In this embodiment, the medical device 1800 also includes a PT coil orPT strand 1835 disposed along the length of the expandable implant 1810to provide for a portion of the expandable implant 1810 to beradiopaque. As shown in FIG. 23, the PT strand 1835 is disposed along alength of the expandable implant 1810 and across or within thepetal-like portions 1825. The PT strand 1835 can be coupled to, forexample, marker bands (not shown) disposed on a proximal end and adistal end of the expandable implant 1810. In some embodiments, a PTstrand 1835 can be braided within the mesh of the expandable implant1810.

In some embodiments, the PT strand 1835 can also be used to preventover-stretching of the expandable implant 1810 when being delivered to atreatment site. For example, as described above, the PT strand 1835 canbe coupled to the proximal end and the distal end of the expandableimplant 1810. Thus, the PT strand 1835 can define a maximum length inwhich the expandable implant 1810 can be stretched or extendedlengthwise during insertion and prevent overstretching. In alternativeembodiments, a separate component can be used to limit the length of theexpandable implant 1810. For example, in some embodiments, a separatewire member in addition to a PT strand can be used. In some embodiments,an expandable implant may not include a PT strand, such as PT strand1835. In such embodiments, a separate wire member can be coupled to theproximal end and distal end of the expandable member and used to limitthe length or amount of stretch of the expandable implant in a similarmanner.

In some embodiments, a medical device can include a strand formed with,for example, a suture that extends along or within the medical device.The suture strand can reinforce the medical device along its length. Insome embodiments, a radiopaque coil can be placed over the suture strandto enhance visibility of the medical device under fluoroscopy.

FIGS. 25-27 illustrate a portion of another embodiment of a medicaldevice. The medical device 1900 can include the same or similar featuresand functions as described above for previous embodiments. For example,the medical device 1900 includes an expandable implant 1910 and aninsertion portion or member (not shown in FIGS. 25-27). The expandableimplant 1910 can be moved between a collapsed configuration (as shown inFIG. 25, a partially expanded configuration as shown in FIG. 26, and anexpanded configuration as shown in FIG. 27.

The expandable implant 1910 includes a ribbon-like strand of porous meshthat includes a first portion 1920 (see FIGS. 25-27) and a secondportion 1930 (shown only in FIG. 27). In this embodiment, the firstportion 1920 and the second portion 1930 are separate components thatcan be deployed together. The first portion 1920 includes disc-shapedportions 1945 along its length, and the second portion 1930 includespetal-like portions 1925, as described above for previous embodiments.When the expandable implant 1910 is in its expanded configuration, theexpandable implant 1910 has a three-dimensional shape (e.g., asubstantially spherical shape) as shown in FIG. 27.

During deployment of the medical device 1900, the second portion 1930can be deployed first such that the petal-like portions 1925 are movedto an expanded configuration and define an interior region 1936. Thefirst portion 1920 can then be deployed such that the disc-shapeportions 1945 will collapse upon each other (as shown in FIGS. 26 and27) within the interior region 1936 of the second portion 1930, as shownin FIG. 27. In other words, when the expandable implant 1910 is in theexpanded configuration, the second portion 1930 at least partiallyoverlaps the first portion 1920, as shown in FIG. 27. At least a portionof the porous mesh is configured to be positioned over a neck of ananeurysm when the expandable implant 1910 is in the expandedconfiguration. For example, when the expandable implant 1910 is in itsexpanded configuration, the second portion 1930 can be disposed at theneck of the aneurysm to disrupt blood flow, and the first portion 1920can help occlude the aneurysm at a relatively fast rate. Although thisembodiment illustrates the first portion 1920 and the second portion1930 as separate components, in an alternative embodiment, the firstportion 1920 and the second portion 1930 can be formed with a singlemesh component.

In this embodiment, the medical device 1900 can also include a PT coilor PT strand (not shown) disposed along the length of first portion 1920and/or the second portion 1930 of the expandable implant 1910 in asimilar manner as described above for medical device 1800. The PT strandcan be coupled to a first marker band 1942 disposed at a first end 1912of the expandable implant 1910 and a second marker band 1944 disposed ona second end of the expandable implant 1910 as shown in FIG. 27. Asdescribed above, the PT strand can be braided within the mesh of theexpandable implant 1910. As shown in FIGS. 26 and 27, the expandablemember 1910 also includes a connector member 1952 that can be used tocouple the expandable member 1910 to a detachment device as described inmore detail below (see e.g., discussion of FIG. 40).

FIGS. 28 and 29 illustrate another embodiment of a medical device. Amedical device 2000 can include all the same or similar features andfunctions as described above for previous embodiments. For example, themedical device 2000 includes an expandable implant 2010, an insertionportion or member 2002, a first radiopaque marker 2042 coupled to afirst end 2012 of the expandable implant 2010 and a second radiopaquemarker 2044 coupled to a second end 2014 of the expandable implant 2010.The expandable implant 2010 can be moved between a collapsedconfiguration (not shown) and an expanded configuration as shown inFIGS. 28 and 29.

In this embodiment, the expandable implant 2010 includes three tubularor rounded strands 2020, 2030 and 2015 formed of a porous mesh similarto the tubular structures described above, for example, with respect toFIGS. 10 and 11. In some embodiments, the strands 2020, 2030 and 2015can be braided. In alternative embodiments, the strands 2020, 2030 and2015 can be formed with ribbon-like strands of porous mesh rather thantubular strands. When the expandable implant 2010 is in its expandedconfiguration, at least a portion of the tubular strands 2020, 2030 and2015 can overlap each other as shown in FIG. 29. The expandable implant2010 can be used to fill a volume of an aneurysm and can be used aloneor in conjunction with another expandable implant to fill the volume ofan aneurysm.

The tubular mesh can be, for example, 1 mm tubular mesh. In thisembodiment, the tubular strands 2020, 2030, 2015 can be heat-shaped suchthat the expandable implant 2010 has a 2D configuration when theexpandable implant 2010 is in its expanded configuration. In thisembodiment, three tubular strands are included, but in alternativeembodiments a different number of tubular strands can be included. Forexample, an expandable implant can be formed with 1-10 tubular strands.The tubular strands 2020, 2030 and 2015 can be coupled together atvarious locations along their lengths with marker bands, such as markerband 2046 shown in FIG. 29. In alternative embodiments, the tubularstrands can be twisted together, or braided together rather than usingmarker bands. In some embodiments, the strands are not coupled together.

FIG. 30 illustrates another embodiment of a medical device includingtubular structures. A medical device 2100 can include all the same orsimilar features and functions as described above for previousembodiments. For example, the medical device 2100 includes an expandableimplant 2110 and an insertion portion or member 2102. Although not shownin FIG. 30, the medical device 2100 can also include radiopaque markerscoupled to end portions to the expandable implant 2110. The expandableimplant 2110 can be moved between a collapsed configuration (not shown)and an expanded configuration as shown in FIG. 30.

The expandable implant 2110 includes three tubular or rounded strands2120, 2130 and 2115 formed of a porous mesh similar to the tubularstrands described above for medical device 2000. When the expandableimplant 2110 is in its expanded configuration, at least a portion of thetubular strands 2120, 2130 and 2115 can overlap each other as shown inFIG. 30. In this embodiment, the tubular strands 2120, 2130, 2115 can beheat-shaped to have a 3D configuration when the expandable implant 2110is in the expanded configuration. In this embodiment, three tubularstrands are included, but in alternative embodiments a different numberof tubular strands can be included. For example, an expandable implantcan be formed with 1-10 tubular strands. The tubular strands 2120, 2130and 2115 can be coupled together at various locations along theirlengths with marker bands (not shown) as described above for medicaldevice 2000, or can be coupled using other coupling methods, such asbeing twisted together, or braided together. In some embodiments, thetubular strands are not coupled together.

FIG. 31 illustrates another embodiment of a medical device includingtubular structures. A medical device 2200 can include all the same orsimilar features and functions as described above for previousembodiments. For example, the medical device 2200 includes an expandableimplant 2210 and an insertion portion or member 2202. Although not shownin FIG. 31, the medical device 2200 can also include radiopaque markerscoupled to end portions to the expandable implant 2210, such asradiopaque marker 2242 coupled to an end 2212 shown in FIG. 31. Theexpandable implant 2210 can be moved between a collapsed configuration(not shown) and an expanded configuration as shown in FIG. 31.

In this embodiment, the expandable implant 2210 includes a singletubular or rounded braid structure 2215 formed of a porous mesh similarto the tubular structures described above for medical devices 2000 and2100. When the expandable implant 2210 is in its expanded configuration,at least a first portion of the tubular structure 2215 can overlap asecond portion of the tubular structure 2215, as shown in FIG. 31. Inthis embodiment, the tubular structure 2215 is formed in a 2D shapeconfiguration and the tubular structure is formed with a larger porositymesh than medical devices 2000 and 2100. For example, the tubularstructure 2215 can be formed with a 3 mm mesh.

FIGS. 32-33 illustrate a portion of another embodiment of a medicaldevice. The medical device 2400 can include the same or similar featuresand functions as described above for previous embodiments. The medicaldevice 2400 includes an expandable implant 2410 and can include aninsertion portion or member (not shown in FIGS. 32-33). The expandableimplant 2410 can be moved between a collapsed configuration as shown inFIG. 32 and an expanded configuration as shown in FIG. 33.

In this embodiment, the expandable implant 2410 includes a first portion2420 formed with a ribbon-like strand of porous mesh and includespetal-like portions 2425, and a second portion 2430 in the form of atubular or rounded strand 2415 formed of a porous mesh similar to thetubular strands described above, for example, with respect to FIGS.28-30. The tubular strand 2415 can be heat formed as either a 2D or 3Dconfiguration. In some embodiments, the tubular strand 2415 can bebraided.

When the expandable implant 2410 is in its expanded configuration, atleast a portion of the first portion 2420 (e.g., petal-like portions2425) can overlap the tubular strand 2415 of the second portion 2430. Atleast a portion of the expandable implant 2410 is configured to bepositioned over a neck of an aneurysm when the expandable implant 2410is in the expanded configuration. The petal-like portions 2425 and thetubular strand 2415 can each be a variety of different sizes (e.g.,diameters), such that when the expandable implant 2410 is moved to itsexpanded configuration, the petal-like portions 2425 of the secondportion 2410 define an interior region and the tubular strand 2415 ofthe first portion 2420 substantially fills the interior region of thesecond portion 2430. Thus, the tubular strand 2415 can be used as afiller to substantially fill a volume of an aneurysm as described abovefor expandable implants 2010 and 2110.

The first portion 2420 and the second portion 2430 can be coupledtogether, for example, with marker bands at end portions of the firstportion 2420 and the second portion 2430 and/or at other locations alonga length of each of the first portion 2420 and the second portion 2430.The first portion 2420 and the second portion 2430 can have the same orsubstantially the same length or can have different lengths. Forexample, in some embodiments, the second portion 2430 can be longer thanthe first portion and vice versa.

The expandable implant 2410 also includes a first radiopaque marker band2442 disposed at a first end 2412 of the expandable member and a secondradiopaque marker band 2444 disposed at a second end 2414 of theexpandable implant 2410 as shown in FIG. 35, which is a schematicillustration of the expandable implant 2410. As shown in FIG. 34, whichis a schematic illustration of the expandable implant 2410, theexpandable member 2410 also includes a connector member 2452 that can beused to couple the expandable member to a detachment device as describedin more detail below.

FIGS. 35-37 are each a schematic illustration of an insertion devicethat can be used to insert and deploy an implant, such as an expandableimplant as described herein, at a desired location within a patient'sbody (e.g., within an aneurysm). An insertion device 2554 can be used inconjunction with a cannula, such as, for example, the cannula 104described herein. For example, the insertion device 2254 can be usedinstead of the insertion portion 102 described herein and can bereleasably or removably coupled to an implant as described in moredetail below.

The insertion device 2554 includes a first elongate member 2556 defininga lumen 2557 through which a second elongate member 2558 can be movablydisposed. A marker band 2564 is coupled to a distal end portion of thefirst elongate member 2556. An expandable coupling member 2562 is alsocoupled to the distal end portion of the first elongate member 2556, forexample, by adhesively coupling a portion of the expandable couplingmember 2562 between the marker band 2564 and an outer wall of the firstelongate member 2556. The expandable coupling member 2562 can be variouslengths and can in some embodiments have a length, for example, of about1-2 mm. The expandable coupling member 2562 can be formed, for example,with a mesh material and/or a braided material.

The second elongate member 2558 can be, for example, a core wire andincludes a ball member 2560 (also referred to as a “coupling member”)disposed at a distal end of the second elongate member 2558. The secondelongate member 2558 can be moved between a first position in which theball member 2560 is disposed outside of the expandable coupling member2562 as shown in FIGS. 35 and 37, and a second position in which theball member 2560 is disposed within an interior region defined by theexpandable coupling member 2562 as shown in FIG. 36. Although the ballmember 2560 is shown circular shaped, in alternative embodiments, theball member 2560 can be other shapes, such as, for example, oval,elliptical, square, rectangular, triangular or other desired shapes (asshown in a side view).

To insert and deploy an expandable implant (e.g., an expandable implantas described herein) within a patient's body, a proximal end portion ofthe expandable implant can be coupled to a distal end portion of theinsertion device 2554. Specifically, as shown in FIG. 35, an expandableimplant 2510 (also referred to as “implant”) can include an outer markerband 2543 and an inner marker band 2541 each coupled to a proximal endportion 2512 of the implant 2510. The outer marker band 2543 can be usedto hold the implant 2510, and the inner marker band 2541 can be disposedwithin the outer marker band 2543. The inner marker band 2541 canprovide a channel through which a distal end portion of the insertiondevice 2554, including the expandable coupling member 2562 and the ballmember 2560, can be inserted. The second elongate member 2558 is thenpulled proximally (in a direction of arrow A in FIG. 36) causing theball member 2560 to become wedged within the expandable coupling member2562 as shown in FIG. 36. For example, the expandable coupling member2562 can be moved between collapsed or relaxed configuration as shown inFIG. 35 to an expanded configuration as shown in FIG. 36 in which theexpandable coupling member 2562 flexes outward or expands as the ballmember 2560 is moved proximally within the expandable coupling member2562. A locking mechanism (not shown) can be used to lock the secondelongate member 2558 in position relative to the first elongate member2556. For example, a handle (not shown) can be coupled to the secondelongate member 2558 and can include a locking mechanism that can lockthe second elongate member 2558 in the position shown in FIG. 36. Withthe expandable coupling member 2562 expanded as shown in FIG. 36, theimplant 2510 is maintained coupled to the insertion device 2554.

With the insertion device 2554 coupled to the implant 2510, a distal endportion of the implant 2510 can be inserted into, for example, aninsertion cannula or catheter (not shown) (e.g., cannula 102 describedabove), and the insertion cannula can be used to insert the implant 2510into a blood vessel in a similar manner as described above with respectto FIGS. 1 and 2. For example, the implant 2510 with the insertiondevice 2554 coupled thereto can be inserted into the insertion cannulasuch that the implant 2510 is moved into a collapsed configuration. Theinsertion cannula can then be inserted into a blood vessel of thepatient to deliver the implant 2510 to a desired location (e.g., ananeurysm) within the patient. At the desired location, the implant 2510can be moved out of a distal end of the cannula and moved to itsexpanded configuration as described above. After the implant 2510 hasbeen deployed, the implant 2510 can be detached from the insertiondevice 2554. Specifically, to detach the insertion device 2554 from theimplant 2510, the second elongate member 2558 is unlocked and moveddistally (in a direction of arrow B shown in FIG. 37) such that the ballmember 2560 is moved distally outside the expandable coupling member2562 allowing the expandable coupling member 2562 to move back to itscollapsed or relaxed configuration as shown in FIG. 37. The insertiondevice 2554 can then be removed by pulling the insertion device 2554proximally (in a direction of arrow A in FIG. 37).

FIG. 38 is a schematic illustration of another embodiment of aninsertion device that can be used to insert and deploy an implant, suchas an expandable implant as described herein. An insertion device 2654can be used in conjunction with a cannula and can be releasably orremovably coupled to an implant, as described above for insertion device2554.

The insertion device 2654 includes a first elongate member 2656 defininga lumen 2657 through which a second elongate member 2658 can be movablydisposed. A coupling element 2666 is coupled to a distal end portion ofthe first elongate member 2656, for example, by gluing a portion of thecoupling element 2666 to an interior wall of the first elongate member2656. The coupling element 2666 can include, for example, a length ofsuture material, and can be various lengths. For example, the couplingelement 2666 can in some embodiments have a length of about 1-2 mm. Thefirst elongate member 2656 can also include a marker band 2664 similarto the marker band 2564 that can be coupled to a distal end portion ofthe first elongate member 2656.

The second elongate member 2658 includes a ball member 2660 disposed ata distal end of the second elongate member 2658 and can be moved betweena first position in which the ball member 2660 is disposed at a distancefrom the coupling element 2666 (e.g., at a position distal of thecoupling element 2666), and a second position in which the ball member2660 is disposed in contact with the coupling element 2666. For example,when the second elongate member 2658 is in its second position, the ballmember 2660 is disposed at a location along a length of the couplingelement 2666 and contacting the coupling element 2666 such that aninterference fit is created between the ball member 2660 and thecoupling element 2666 as shown in FIG. 38.

To insert and deploy an expandable implant, such as the expandableimplants described herein, within a patient's body, a proximal endportion of the expandable implant (also referred to as “implant”) can becoupled to a distal end portion of the insertion device 2654.Specifically, the implant can include an outer marker band 2643 and aninner marker band 2641 each coupled to a proximal end portion of theimplant. As with the previous embodiment, the outer marker band 2643 canbe used to hold the implant and the inner marker band 2641 can bedisposed within the outer marker band 2643 and provide a channel 2647through which the distal end portion of the insertion device 2654 can beinserted.

With the second elongate member 2658 in its first position (i.e., withthe ball member 2660 disposed at a distance from the coupling element2666) and the coupling element 2666 in its first configuration, the ballmember 2660 and the coupling element 2666 are inserted through the innermarker band 2641 and disposed within the implant. The second elongatemember 2658 is then pulled proximally (in the direction of arrow A inFIG. 38) such that the second elongate member 2658 is moved to itssecond position (with the ball member 2660 contacting the couplingelement 2666) and the coupling element 2666 is moved to a secondconfiguration as shown in FIG. 38. When the second elongate member 2658is in its second position and the coupling element 2666 is in its secondconfiguration an interference fit is created between the ball member2660 and the coupling element 2666. This interference fit holds theimplant to the insertion device 2654. As described above for theprevious embodiment, a locking mechanism (not shown) can be used to lockthe second elongate member 2658 in position relative to the firstelongate member 2656. For example, a handle 2655 is coupled to thesecond elongate member 2658 and can include a locking mechanism (notshown) that can lock the second elongate member 2658 in its secondposition, as shown in FIG. 38.

With the insertion device 2654 coupled to the implant, a distal endportion (not shown) of the implant can be inserted into, for example, aninsertion cannula (not shown) (e.g., cannula 102 described above), andthe insertion cannula can be used to insert the implant into a bloodvessel in a similar manner as described above with respect to FIGS. 1and 2 and FIGS. 35-37. For example, the implant with the insertiondevice 2654 coupled thereto can be pushed distally within the cannula tomove the implant to a collapsed configuration. The cannula can then beinserted into a blood vessel of the patient to deliver the implant to adesired location within the patient, such as, for example, within ananeurysm, as described above. After the implant has been deployed (e.g.,moved out of a distal end of the cannula), the insertion device 2654 canbe detached from the implant in a similar manner as described above forthe previous embodiment. Specifically, to detach the insertion device2654 from the implant, the second elongate member 2658 is unlocked andmoved distally (in the direction of arrow B in FIG. 38) such that theball member 2660 is moved away (e.g., distally) from the couplingelement 2666, eliminating the interference fit between the ball member2660 and the coupling element 2666. The insertion device 2654 can thenbe removed by pulling the insertion device 2654 proximally (in adirection of arrow A in FIG. 38).

FIG. 39 illustrates an embodiment of an insertion device 2754 that issimilar to the insertion device 2654. The insertion device 2754 caninclude the same as or similar features and function the same as orsimilar to the insertion device 2654. For example the insertion device2754 can be used in the deployment of an implant as described above. Theinsertion device 2754 includes a first elongate member 2756 defining alumen (not shown) through which a second elongate member 2758 (e.g., acore wire) can be movably disposed. A coupling element 2766 is coupledto a distal end portion of the first elongate member 2756, for example,by gluing a portion of the coupling element 2766 to an interior wall ofthe first elongate member 2756. The coupling element 2766 can be variouslengths and can in some embodiments have a length, for example, of about1-2 mm. The first elongate member 2756 can also include a marker band(not shown) coupled to a distal end portion of the first elongate member2756.

A ball member 2760 is disposed at a distal end of the second elongatemember 2758 and the second elongate member 2758 can be moved between afirst position in which the ball member 2760 is disposed at a distancefrom the coupling element 2766 (e.g., distal of the coupling element2766) as shown in FIG. 40 and a second position in which the ball member2760 is disposed in contact with the coupling element 2766 at a locationalong a length of the coupling element 2762 such that an interferencefit is created between the ball member 2760 and the coupling element2766. The insertion device 2754 can be used to insert and deploy animplant and be detached from the implant in the same or similar manneras described above for insertion device 2654.

FIG. 40 is a schematic illustration of another embodiment of aninsertion device that can be used to insert and deploy an implant, suchas an expandable implant as described herein. An insertion device 2854can be used in conjunction with a cannula and can be releasably orremovably coupled to an implant, as described above for example, forinsertion device 2554.

The insertion device 2854 includes a first elongate member 2856 defininga lumen 2857 through which a second elongate member 2858 can be movablydisposed. The first elongate member 2856 can also include a marker band(not shown) coupled to a distal end portion of the first elongate member2756. An insertion ball member 2860 is disposed at a distal end of thesecond elongate member 2858. The insertion device 2854 can be coupled toan expandable implant 2810 similar to or the same as the expandableimplants described herein. The expandable implant 2810 includes a markerband 2842 and a connector member 2852 coupled to the marker band 2842.The connector member 2852 includes a wire 2868 coupled to the markerband 2842 and/or the implant 2810 and an implant ball member 2870coupled to (or formed integrally or monolithically with) the wire 2868.The wire 2868 and implant ball member 2870 collectively can have alength L that in some embodiments can be, for example, 1.5 mm. Althoughnot discussed in detail above, the connector members 1652, 1952, 2352,and 2452 described above for previous embodiments of an expandableimplant can include the same or similar features and functions as theconnector 2852.

To insert and deploy the expandable implant 2810 within a patient'sbody, the expandable implant 2810 is first coupled to the insertiondevice 2854. Specifically, the second elongate member 2858 is moveddistally (in a direction of arrow B in FIG. 40) such that the insertionball member 2860 is disposed outside a distal end of the first elongatemember 2856. The implant ball member 2870 is then inserted into thedistal end of the first elongate member 2856 as shown in FIG. 40. Thesecond elongate member 2858 is then moved proximally (in the directionof arrow A in FIG. 40) such that the insertion ball member 2860 locks ortraps the implant ball member 2870 within the lumen 2857 of the firstelongate member 2856 as shown in FIG. 40. For example, each of theinsertion ball member 2860 and the implant ball member 2870 can have adiameter greater than half the diameter of the lumen 2857 of the firstelongate member 2856 such that when the implant ball member 2870 isdisposed within the lumen 2857 and the insertion ball member 2860 ismoved proximally into the lumen 2857, the implant ball member 2860cannot be pulled back out of the lumen 2857.

With the implant ball member 2870 trapped within the lumen 2857 of thefirst elongate member 2856, the expandable implant 2810 will be held tothe insertion device 2854. As described above for the previousembodiment, a locking mechanism (not shown) can be used to lock thesecond elongate member 2658 in this position relative to the firstelongate member 2856. With the insertion device 2854 coupled to theexpandable implant 2810, a distal end portion of the expandable implant2810 can be inserted into, for example, an insertion cannula (not shown)(e.g., cannula 102 described above), and the insertion cannula can beused to insert the implant 2810 into a blood vessel in a similar manneras described above with respect to previous embodiments. After theexpandable implant 2810 has been deployed, the insertion device 2854 canbe detached from the expandable implant 2810 in a similar manner asdescribed above for the previous embodiment. Specifically, to detach theinsertion device 2854 from the expandable implant 2810, the secondelongate member 2858 is unlocked and moved distally (in the direction ofarrow B) such that the insertion ball member 2860 is moved distallyoutside of the first elongate member 2856, un-trapping the implant ballmember 2870. The insertion device 2854 can then be removed by pullingthe first elongate member 2856 and the second elongate member 2858proximally.

FIG. 41 is a flowchart illustrating a method of deploying an expandableimplant within an aneurysm using an insertion device as describedherein. The method includes, at 2982, coupling a distal end portion ofan insertion device to a proximal end portion of an expandable implant.For example, the insertion device can be an insertion device asdescribed herein and the expandable implant can be an expandable implantas described herein. The insertion device can include a first elongatemember that defines a lumen and a second elongate member movablydisposed at least partially within the lumen of the first elongatemember. The coupling can include moving the second elongate memberproximally relative to the first elongate member such that a firstcoupling member on a distal end of the second elongate member engages asecond coupling member on at least one of the first elongate member orthe expandable implant and secures a portion of the expandable implantto the insertion device. In some embodiments, the second coupling membercan be disposed on the first elongate member, and the moving the secondelongate member proximally relative to the first elongate member causesthe second coupling member to be moved from a collapsed configuration toan expanded configuration. In some embodiments, the second couplingmember is disposed on the expandable implant, and prior to moving thesecond elongate member proximally, the second coupling member isinserted through a distal end of the first elongate member such that thesecond coupling member is disposed within the lumen of the firstelongate member.

At 2984, the expandable implant can be inserted within a blood vessel ofa patient while the expandable implant is in a collapsed configurationand coupled to the insertion device. For example, the expandable implantcan be moved to a collapsed configuration using a cannula as describedherein. At 2986, the expandable implant can be deployed within ananeurysm such that the expandable implant moves to an expandedconfiguration within the aneurysm. For example, the expandable implantcan be moved outside the cannula such that it can move to its expandedconfiguration. At 2988, the insertion device can be decoupled from theexpandable implant, and at 2990, the insertion device can be removedfrom the blood vessel of the patient.

FIGS. 42 and 43 illustrate a portion of another embodiment of a medicaldevice. The medical device 3000 can include the same or similar featuresand functions as described above for previous embodiments. For example,the medical device 3000 includes an expandable implant 3010 and aninsertion portion or member 3002. The expandable implant 3010 can bemoved between a collapsed configuration, as shown in FIG. 43 and anexpanded configuration, as shown in FIG. 42.

The expandable implant 3010 includes a ribbon-like strand of porous meshthat includes a first portion 3020 and a second portion 3030 formed as asingle component. In this embodiment, when the expandable implant 3010is in the expanded configuration, the second portion 3030 forms aball-like structure that defines an interior region 3036 and the firstportion 3020 can be deployed within the interior region 3036.Specifically, during deployment of the medical device 3000, the secondportion 3030 can be deployed first such that it can be expanded to theball-shaped structure within an aneurysm, and then the first portion3020 can be deployed within the interior region 3036 to substantiallyfill the second portion 3030 as shown in FIG. 42.

FIGS. 44-46 illustrate a portion of another embodiment of a medicaldevice. The medical device 3100 can include the same or similar featuresand functions as described above for previous embodiments. For example,the medical device 3100 includes an expandable implant 3110 and aninsertion portion or member 3102. The expandable implant 3110 can bemoved between a collapsed configuration, as shown in FIG. 45 and anexpanded configuration, as shown in FIG. 44.

The expandable implant 3110 is an example of a multi-layer implant thatincludes a ribbon-like strand of porous mesh that includes a firstportion 3130, a second portion 3120 and a third portion 3115 formed witha single mesh component. Such an embodiment may be desirable in that theimplant can fit in a small delivery catheter, but can have high flowdisruption by having more than two layers of material, and forming thelayers in-vivo. For example, in this embodiment, when the expandableimplant 3110 is in the expanded configuration, the second portion 3120can be expanded within the third portion 3115 and the first portion 3130can be expanded within the second portion 3120. Specifically, duringdeployment within an aneurysm A, as shown in FIG. 46, the medical device3100 can first be inserted into a delivery catheter 3104 such that theexpandable implant 3110 is moved to its collapsed configuration. At thedeployment site, the expandable implant 3110 can be moved outside thedelivery catheter 3104 and deployed within an aneurysm. Duringdeployment, the third portion 3115 can be deployed first, then thesecond portion 3120 can be deployed within an interior region defined bythe third portion 3115, and then the first portion 3130 can be deployedwithin an interior region defined by the second portion 3120. FIG. 46illustrates the expandable implant 3110 with the third portion 3115 andthe second portion 3120 deployed and the first portion 3130 still withinthe catheter 3104. In some embodiments, the insertion portion 3102 canbe coupled to the second portion 3120, such that during detachment ofthe insertion portion 3102 (e.g., after the expandable implant 3110 hasbeen deployed within an aneurysm), the detachment can occur inside thesecond portion to avoid any part of the implant from extending orhanging within the blood vessel V.

FIG. 47 is a schematic illustration of another embodiment of aninsertion device that can be used to insert and deploy an implant, suchas an expandable implant as described herein. An insertion device 3254can be used in conjunction with a cannula or catheter, and can bereleasably or removably coupled to an implant, as described for previousembodiments.

The insertion device 3254 includes a first elongate member 3256 defininga lumen 3257 through which a second elongate member 3258 can be movablydisposed. The first elongate member 3256 includes an inner marker band3265 coupled to a distal end portion of the first elongate member 3256.In this embodiment, a distal end portion 3267 of the second elongatemember 3258 is tapered as shown in FIG. 47. The insertion device 3254also includes a handle 3255 disposed at a proximal end portion of theinsertion device 3254.

The insertion device 3254 can be coupled to an expandable implant 3210similar to, or the same as, the expandable implants described herein.The expandable implant 3210 includes a marker band 3242 and a connectormember 3252 coupled to the marker band 3242. The connector member 3252can be similar to or the same as, for example, the connector member 2852described above. For example, the connector member 3252 includes a wire3268 coupled to the marker band 3242 and an implant ball member 3270coupled to (or formed monolithically or integrally with) the wire 3268.

To insert and deploy the expandable implant 3210 within a patient'sbody, the expandable implant 3210 is first coupled to the insertiondevice 3254. Specifically, in this embodiment, the second elongatemember 3258 is moved proximally (in a direction of arrow A in FIG. 47)such that the tapered distal end portion 3267 is moved proximally withinthe lumen 3257. This allows the implant ball member 3270 to be insertedinto the lumen 3257 of the first elongate member 3256. The secondelongate member 3258 is then moved distally (in the direction of arrow Bin FIG. 47) such that the tapered distal end portion 3267 of the secondelongate member 3256 engages the implant ball member 3270 and traps orwedges the implant ball member 3270 within the lumen 3257 of the firstelongate member 3256 between the tapered distal end portion 3267 and theinner marker band 3265.

With the implant ball member 3270 locked or wedged within the lumen 3257of the first elongate member 3256, the expandable implant 3210 will beheld to the insertion device 3254. As described above for previousembodiments, a locking mechanism (not shown) coupled to the handle 3255can be used to lock the second elongate member 3258 in this positionrelative to the first elongate member 3256. With the insertion device3254 coupled to the expandable implant 3210, the expandable implant 3210can be inserted into, for example, an insertion cannula (not shown)(e.g., cannula 102 described above) to move the expandable implant 3210to a collapsed configuration, and the insertion cannula can be used toinsert the implant into a blood vessel in a similar manner as describedabove with respect to previous embodiments.

After the expandable implant 3210 has been deployed within, for example,an aneurysm, the insertion device 3254 can be detached from theexpandable implant 3210 and removed from the patient's body.Specifically, to detach the insertion device 3254 from the expandableimplant 3210, in this embodiment, the second elongate member 3258 isunlocked from the handle 3255 and moved proximally (in the direction ofarrow A) such that the tapered distal end portion 3267 is movedproximally and disengages the implant ball member 3270. With the tapereddistal end portion 3267 moved proximally, the implant ball member 3260will be free to move outside of the lumen 3257 of the first elongatemember 3256. The insertion device 3254 can then be removed by pullingthe insertion device 3254 proximally.

FIG. 48 is a schematic illustration of another embodiment of aninsertion device that can be used to insert and deploy an implant, suchas an expandable implant as described herein. An insertion device 3354can be used in conjunction with a cannula or catheter, and can bereleasably or removably coupled to an implant, as described for previousembodiments.

The insertion device 3354 includes a first elongate member 3356 defininga lumen 3357 through which a second elongate member 3358 can be movablydisposed. The first elongate member 3356 includes a tapered distal endportion 3392 as shown in FIG. 48. In alternative embodiments, the firstelongate member 3356 can have a constant diameter as with previousembodiments. The first elongate member 3356 also includes an outermarker band 3364 coupled to the tapered distal end portion 3392. Aninsertion ball member 3360 is disposed at a distal end of the secondelongate member 3358 as shown in FIG. 48. The insertion device 3354 canalso include a handle (not shown) disposed at a proximal end portion ofthe insertion device 3354 as described above for previous embodiments.

The insertion device 3354 can be coupled to an expandable implant 3310similar to, or the same as, the expandable implants described herein.The expandable implant 3310 includes a marker band 3342 at a proximalend portion of the expandable implant 3310, and a connector member 3352coupled to the marker band 3342. The connector member 3352 can besimilar to, or the same as, for example, the connector member 2852described above. For example, the connector member 3352 includes a wire3368 coupled to the marker band 3342 and an implant ball member 3370coupled to (or formed monolithically or integrally with) the wire 3368.In this embodiment, as shown in FIG. 48, the insertion ball member 3360is larger than the implant ball member 3370 and defines a slot 3371 on aside portion thereof through which the wire 3368 of the connector member3352 can be disposed when the implant 3310 is coupled to the insertiondevice 3354.

To insert and deploy the expandable implant 3310 within a patient'sbody, the expandable implant 3310 is first coupled to the insertiondevice 3354. Specifically, in this embodiment, the second elongatemember 3358 is moved distally (in a direction of arrow B in FIG. 48)such that insertion ball member 3360 is moved distally outside of thelumen 3357 of the first elongate member 3356. The implant ball member3370 can be inserted into the lumen 3357 of the first elongate member3356 and the wire 3368 can be placed or disposed within the slot 3371 ofthe insertion ball member 3360. The second elongate member 3358 is thenmoved proximally (in the direction of arrow A in FIG. 48) such that theinsertion ball member 3360 and the implant ball member 3370 are movedinto the lumen 3357 of the first elongate member 3356 and the insertionball member 3360 locks or traps the implant ball member 3370 within thelumen 3357 of the first elongate member 3356 as shown in FIG. 48.

With the implant ball member 3370 trapped within the lumen 3357 of thefirst elongate member 3356, the expandable implant 3310 will be coupledto the insertion device 3354. As described above for previousembodiments, a locking mechanism (not shown) coupled to the handle (notshown) can be used to lock the second elongate member 3358 in thisposition relative to the first elongate member 3356. With the insertiondevice 3354 coupled to the expandable implant 3310, the expandableimplant 3310 can be inserted into, for example, an insertion cannula(not shown) to move the expandable implant 3310 to a collapsedconfiguration. The insertion cannula can be used to insert the implant3310 into a blood vessel in a similar manner as described above withrespect to previous embodiments.

After the expandable implant 3310 has been deployed within, for example,an aneurysm, the insertion device 3354 can be detached from theexpandable implant 3310 and removed from the patient's body.Specifically, to detach the insertion device 3354 from the expandableimplant 3310, in this embodiment, the second elongate member 3358 isunlocked from the handle 3355 and moved distally (in the direction ofarrow B in FIG. 48) such that the insertion ball member 3360 is moveddistally allowing the implant ball member 3370 to be free to be movedoutside of the lumen 3357 of the first elongate member 3356. Theinsertion device 3354 can then be removed by pulling the insertiondevice 3354 proximally.

FIG. 49 is a schematic illustration of another embodiment of aninsertion device that can be used to insert and deploy an implant, suchas an expandable implant as described herein. An insertion device 3454can be used in conjunction with a cannula or catheter, and can bereleasably or removably coupled to an implant, as described for previousembodiments.

The insertion device 3454 includes a first elongate member 3456 defininga lumen 3457 through which a second elongate member 3458 can be movablydisposed. The first elongate member 3458 includes a tapered distal endportion 3492 as shown in FIG. 49, but can in alternative embodimentshave a constant diameter. The first elongate member 3456 also includesan outer marker band 3464 coupled to the tapered distal end portion3492. A plunger or bumper member 3494 is disposed at a distal end of thesecond elongate member 3458, as shown in FIG. 49. The insertion device3454 can also include a handle (not shown) disposed at a proximal endportion of the insertion device 3454 as described above for previousembodiments.

The insertion device 3454 can be coupled to an expandable implant 3410similar to, or the same as, the expandable implants described herein.The expandable implant 3410 includes a marker band 3442 at a proximalend portion of the expandable implant 3410, and a connector member 3452coupled to the marker band 3442. The connector member 3452 can besimilar to, or the same as, for example, the connector member 2852described above and includes a wire 3468 coupled to the marker band 3442and an implant ball member 3470 coupled to (or formed monolithically orintegrally with) the wire 3468.

To insert and deploy the expandable implant 3410 within a patient'sbody, the expandable implant 3410 is first coupled to the insertiondevice 3454. Specifically, in this embodiment, the second elongatemember 3458 is moved distally (in a direction of arrow B in FIG. 49)such that insertion plunger member 3494 is moved distally outside of thelumen 3457 of the first elongate member 3456. The implant ball member3470 can then be inserted into the lumen 3457 of the first elongatemember 3456. The second elongate member 3458 is then moved distally (inthe direction of arrow B in FIG. 49) such that the plunger member 3494locks or traps the insertion ball member 3470 within the lumen 3457 ofthe first elongate member 3456 as shown in FIG. 49.

With the implant ball member 3470 trapped within the lumen 3457 of thefirst elongate member 3456, a locking mechanism (not shown) coupled tothe handle (not shown) can be used to lock the second elongate member3458 in this position relative to the first elongate member 3456. Withthe insertion device 3454 coupled to the expandable implant 3410, theexpandable implant 3410 can be inserted into, for example, an insertioncannula (not shown) to move the expandable implant 3410 to a collapsedconfiguration. The insertion cannula can be used to insert the implant3410 into a blood vessel in a similar manner as described above withrespect to previous embodiments.

After the expandable implant 3410 has been deployed within, for example,an aneurysm, the insertion device 3454 can be detached from theexpandable implant 3410 and removed from the patient's body.Specifically, to detach the insertion device 3454 from the expandableimplant 3410, in this embodiment, the second elongate member 3458 isunlocked from the handle and moved distally (in the direction of arrow Bin FIG. 49) such that the plunger member 3494 is moved distally allowingthe implant ball member 3470 to be free to be moved outside of the lumen3457 of the first elongate member 3456. The insertion device 3454 canthen be removed by pulling the insertion device 3454 proximally.

FIG. 50 is a schematic illustration of another embodiment of aninsertion device that can be used to insert and deploy an implant, suchas an expandable implant as described herein. An insertion device 3554can be used in conjunction with a cannula or catheter, and can bereleasably or removably coupled to an implant, as described for previousembodiments.

The insertion device 3554 includes a first elongate member 3556 defininga lumen 3557 through which a second elongate member 3558 can be movablydisposed. The first elongate member 3558 includes a tapered distal endportion 3592 as shown in FIG. 50, but can in alternative embodiments,have a constant diameter. The first elongate member 3556 also includesan outer marker band 3564 coupled to the tapered distal end portion3592. An insertion ball member 3560 is disposed at a distal end of thesecond elongate member 3558, as shown in FIG. 50. In this embodiment,the insertion device 3554 also includes an elongate locking member 3596.The locking member 3596 can have a constant diameter or outer perimeteralong its length or can be tapered. For example a distal end portion ofthe locking member 3596 can have a smaller diameter than a proximal endportion of the locking member 3596. The locking member 3596 is used inconjunction with the insertion ball member 3560 to lock the implant ballmember 3570 to the insertion device 3554 as described in more detailbelow. The insertion device 3554 can also include a handle (not shown)disposed at a proximal end portion of the insertion device 3554 asdescribed above for previous embodiments.

As with previous embodiments, the insertion device 3554 can be coupledto an expandable implant 3510 similar to, or the same as, the expandableimplants described herein. The expandable implant 3510 includes a markerband 3542 at a proximal end portion, and a connector member 3552 coupledto the marker band 3542. The connector member 3552 can be similar to, orthe same as, for example, the connector members described above andincludes a wire 3568 coupled to the marker band 3542 and an implant ballmember 3570 coupled to (or formed monolithically or integrally with) thewire 3568.

To insert and deploy the expandable implant 3510 within a patient'sbody, the expandable implant 3510 is coupled to the insertion device3554. Specifically, in this embodiment, the locking member 3596 is movedproximally (in the direction of arrow A in FIG. 50) such that a distalend portion of the locking member 3596 is disposed proximally of theinsertion ball member 3560. This allows the implant ball member 3570 tobe inserted into the lumen 3557 of the first elongate member 3556. Inother words, the insertion ball member 3560 and the implant ball member3570 can each be sized (e.g., each can have a diameter) such that whenthe locking member 3596 is moved proximally, disengaging the insertionball member 3560, the implant ball member 3570 can be moved in and outof the lumen 3557 while the implant ball member 3570 is disposed withinthe lumen 3557. After the implant ball member 3570 is placed within thelumen 3557 of the first elongate member 3556, the locking member 3596can be moved distally (in a direction of arrow B in FIG. 50) such thatthe distal end portion of the locking member 3596 is wedged between aninner wall of the first elongate member 3556 and the insertion ballmember 3560. With the locking member 3596 in this position, the implantball member 3570 will be held or trapped within the lumen 3557 of thefirst elongate member 3556 as shown in FIG. 50.

With the implant ball member 3570 trapped within the lumen 3557 of thefirst elongate member 3556, a locking mechanism (not shown) coupled tothe handle (not shown) can be used to lock the locking member 3596 inposition relative to the first elongate member 3556. With the insertiondevice 3554 coupled to the expandable implant 3510, the expandableimplant 3510 can be inserted into, for example, an insertion cannula(not shown) to move the expandable implant 3510 to a collapsedconfiguration. The insertion cannula can be used to insert the implant3510 into a blood vessel in a similar manner as described above withrespect to previous embodiments.

After the expandable implant 3510 has been deployed within, for example,an aneurysm, the insertion device 3554 can be detached from theexpandable implant 3510 and removed from the patient's body.Specifically, to detach the insertion device 3554 from the expandableimplant 3510, in this embodiment, the locking member 3596 is unlockedfrom the handle and moved proximally (in the direction of arrow A inFIG. 50) such that the distal end portion of the locking member 3596 ismoved proximally away from the insertion ball member 3560 allowing theimplant ball member 3570 to be free to be moved outside of the lumen3557 of the first elongate member 3556. The insertion device 3554 canthen be removed by pulling the insertion device 3554 proximally.

FIG. 51 is a schematic illustration of another embodiment of aninsertion device that can be used to insert and deploy an implant, suchas an expandable implant as described herein. An insertion device 3654can be used in conjunction with a cannula or catheter, and can bereleasably or removably coupled to an expandable implant, as describedfor previous embodiments.

The insertion device 3654 includes a first elongate member 3656 defininga lumen 3657 through which a second elongate member 3658 can be movablydisposed. The first elongate member 3656 also includes an extensionmember 3672 and a stopper 3674 disposed within the lumen 3657. Theextension member 3672 defines an opening or window 3673. An insertionball member 3660 is disposed at a distal end of the second elongatemember 3658 and a bumper member 3694 disposed at a spaced distanceproximally of the insertion ball member 3660, as shown in FIG. 51. Theinsertion device 3654 can also include a handle 3655 disposed at aproximal end portion of the insertion device 3654 as described above forprevious embodiments.

As with previous embodiments, the insertion device 3654 can be coupledto an expandable implant 3610 similar to, or the same as, the expandableimplants described herein. In this embodiment, the expandable implant3610 includes a marker band 3642 at a proximal end portion, and aconnector member 3652 coupled to the marker band 3642. The connectormember 3652 can be similar to, or the same as, for example, theconnector members described above and includes a wire 3668 coupled tothe marker band 3642 and an implant ball member 3670 coupled to (orformed monolithically or integrally with) the wire 3668.

The expandable implant 3610 can also include a lead-in portion 3676(also referred to herein as “lead-in member”) disposed at a distal endportion of the expandable implant 3610. The lead-in portion 3676 can beformed with, for example, a shape memory material such as nitinol, suchthat the lead-in portion 3676 has a biased curved shape when notconstrained within, for example a cannula. The curved shape of thelead-in portion 3676 can reduce or eliminate possible sharp edges wheninserting the expandable implant 3610 within a vasculature of a patient.The lead-in portion 3676 can be a separate component coupled to theexpandable implant 3610 or can be formed integrally or monolithicallywith the expandable implant 3610. In some embodiments, the lead-inportion 3676 can be crimped to the distal end portion of the expandableimplant 3610. In some embodiments, the lead-in portion 3676 can beformed integrally or monolithically with a wire member or radiopaquewire (as described for example with respect to FIGS. 23 and 24) thatextends through the expandable implant 3610. For example, such a wiremember can extend beyond the distal end portion of the expandableimplant 3610 and form the lead-in portion 3676.

To insert and deploy the expandable implant 3610 within a patient'sbody, the expandable implant 3610 is coupled to the insertion device3654. Specifically, in this embodiment, the second elongate member 3658is moved proximally (in a direction of arrow A in FIG. 51) such that theinsertion ball member 3660 is disposed proximally of the window 3673defined in the extension member 3672. This allows the implant ballmember 3670 to be inserted through an opening (not shown) defined at adistal end of the first elongate member 3656 and into the lumen 3657 ofthe first elongate member 3656. For example, the insertion ball member3660 and the implant ball member 3670 can each be sized (e.g., each canhave a diameter) such that collectively the insertion ball member 3660and the implant ball member 3670 have a size (e.g., a diameter) greaterthan a diameter of the lumen 3657. Thus, the insertion ball member 3660is moved to a position to provide clearance or space for the implantball member 3670 to be inserted into the lumen 3657 and disposed near oradjacent to the window 3673. The second elongate member 3658 can then bemoved distally (in a direction of arrow B in FIG. 51) such that theinsertion ball member 3660 is moved distally and contacts the implantball member 3670 and moves or pushes the implant ball member 3670 atleast partially through the window 3673. The second elongate member 3658is moved distally until the insertion ball member 3660 is moved to aposition distal of the implant ball member 3670, allowing the implantball member 3670 to move back into the lumen 3657. Further, as thesecond elongate member 3658 is moved distally, the bumper member 3694 onthe second elongate member 3658 can contact the stopper 3674 to limitthe movement of the second elongate member 3658 in the distal direction.With the insertion ball member 3660 and the implant ball member 3670interlocked within the lumen 3657 and the implant ball member 3670 nowpositioned proximal of the insertion ball member 3660, the implant 3610is maintained coupled to the insertion device 3654.

With the implant ball member 3670 held or trapped within the lumen 3657of the first elongate member 3656, a locking mechanism (not shown)coupled to the handle 3655 can be used to lock the second elongatemember 3658 in this position relative to the first elongate member 3656.With the insertion device 3654 coupled to the expandable implant 3610,the expandable implant 3610 can be inserted into the lumen of aninsertion cannula 3604 to move the expandable implant 3610 to acollapsed configuration. The insertion cannula 3604 can be used toinsert the implant 3610 into a blood vessel in a similar manner asdescribed above with respect to previous embodiments.

After the expandable implant 3610 has been deployed within, for example,an aneurysm, the insertion device 3654 can be detached from theexpandable implant 3610 and removed from the patient's body.Specifically, to detach the insertion device 3654 from the expandableimplant 3610, the second elongate member 3558 is moved proximally suchthat the insertion ball member 3660 contacts the implant ball member3670 and moves the implant ball member 3670 at least partially withinthe window 3673. The second elongate member 3658 is moved proximallyuntil the insertion ball member 3660 is disposed proximal of the window3673 such that the implant ball member 3670 can move back within thelumen 3657 of the first elongate member 3656. The stopper 3674 can limitthe movement of the second elongate member 3658 by engaging theinsertion ball member 3660. With the implant ball member 3670 disposeddistal of the insertion ball member 3660, the implant 3610 can bereleased from the insertion device 3654. The insertion device 3654 canthen be removed by pulling the insertion device 3654 proximally.

FIG. 52 is a schematic illustration of another embodiment of aninsertion device that can be used to insert and deploy an implant, suchas an expandable implant as described herein. An insertion device 3754can be used in conjunction with a cannula or catheter, and can bereleasably or removably coupled to an implant, as described for previousembodiments.

The insertion device 3754 includes a first elongate member 3756 defininga lumen 3757 through which a second elongate member 3758 can be movablydisposed. The first elongate member 3756 includes an inner stopper 3774coupled to a distal end portion of the first elongate member 3756 withinthe lumen 3757. The inner stopper 3774 defines a channel 3775 that canbe used to trap or hold an implant 3710 to the insertion device 3654 asdescribed in more detail below.

The second elongate member 3758 includes a distal end portion 3767 thatcan be smaller in size (e.g., diameter) than a remaining portion 3777 ofthe second elongate member 3758. In some embodiments, the distal endportion 3767 can be tapered. In some embodiments, the distal end portion3767 can be a separate component coupled to the remaining portion 3777of the second elongate member 3758. The second elongate member 3758 canbe formed for example, with a shape-memory material and define a bend orbends along its length. The insertion device 3754 also includes a handle3755 disposed at a proximal end portion of the insertion device 3754.

The insertion device 3754 can be coupled to an expandable implant 3710similar to, or the same as, the expandable implants described herein.The expandable implant 3710 includes a marker band 3742 and a connectormember 3752 coupled to the marker band 3742. The connector member 3752can be similar to or the same as, for example, the connector membersdescribed above for previous embodiments. For example, the connectormember 3752 includes a wire 3768 coupled to the marker band 3742 and animplant ball member 3770 coupled to (or formed monolithically orintegrally with) the wire 3768.

To insert and deploy the expandable implant 3710 within a patient'sbody, the expandable implant 3710 is first coupled to the insertiondevice 3754. Specifically, in this embodiment, the second elongatemember 3758 is moved proximally (in a direction of arrow A in FIG. 52)such that the distal end portion 3767 is moved proximally within thelumen 3757. This allows the implant ball member 3770 to be inserted intothe lumen 3757 of the first elongate member 3756. The second elongatemember 3758 is then moved distally (in the direction of arrow B in FIG.52) such that the distal end portion 3767 of the second elongate member3756 engages and urges the implant ball member 3770 at least partiallywithin the channel 3775, trapping or wedging the implant ball member3770 within the lumen 3757 of the first elongate member 3756 between thetapered distal end portion 3767 and the inner stopper 3774.

With the implant ball member 3770 wedged or trapped within the lumen3757 of the first elongate member 3756, the expandable implant 3710 willbe held to the insertion device 3754. As described above for previousembodiments, a locking mechanism (not shown) coupled to the handle 3755can be used to lock the second elongate member 3758 in this positionrelative to the first elongate member 3756. With the insertion device3754 coupled to the expandable implant 3710, the expandable implant 3710can be inserted into, for example, an insertion cannula (not shown) tomove the expandable implant 3710 to a collapsed configuration, and theinsertion cannula can be used to insert the implant 3710 into a bloodvessel in a similar manner as described above with respect to previousembodiments.

After the expandable implant 3710 has been deployed within, for example,an aneurysm, the insertion device 3754 can be detached from theexpandable implant 3710 and removed from the patient's body.Specifically, to detach the insertion device 3754 from the expandableimplant 3710, the second elongate member 3758 is unlocked from thehandle 3755 and moved proximally (in the direction of arrow A) such thatthe tapered distal end portion 3767 is moved proximally and disengagesthe implant ball member 3770. With the tapered distal end portion 3767moved proximally, the implant ball member 3770 will be free to moveoutside of the lumen 3757 of the first elongate member 3756. Theinsertion device 3754 can then be removed by pulling the insertiondevice 3754 proximally.

FIG. 53 is a schematic illustration of another embodiment of aninsertion device that can be used to insert and deploy an implant, suchas an expandable implant as described herein. An insertion device 3854can be used in conjunction with a cannula or catheter, and can bereleasably or removably coupled to an implant, as described for previousembodiments.

The insertion device 3854 includes a first elongate member 3856 defininga lumen 3857 through which a second elongate member 3858 can be movablydisposed. The insertion device 3854 can also include a handle (notshown) disposed at a proximal end portion of the insertion device 3854as described above for previous embodiments. The first elongate member3856 includes an inner stopper 3874 coupled to a distal end portion ofthe first elongate member 3856. The inner stopper 3874 can be, forexample, and inner marker band as described above for previousembodiments.

The second elongate member 3858 includes a distal end portion 3867 thatcan engage a portion of an expandable implant as described in moredetail below. In some embodiments, the distal end portion 3867 can betapered. The second elongate member 3858 also includes a bumper member3894 and a coil member 3876. In some embodiments, the distal end portion3867 can be a separate component coupled to the bumper member 3894. Insome embodiments, the distal end portion 3867 is formed integral ormonolithically with a remaining portion 3877 of the second elongatemember 3858. For example, the distal end portion and/or the remainingportion 3877 can extend through a lumen (not shown) of the bumper member3894 and a lumen (not shown) of the coil member 3876, and extend to aproximal end of the insertion device 3854.

The insertion device 3854 can be coupled to an expandable implant 3810similar to, or the same as, the expandable implants described herein.The expandable implant 3810 includes a marker band 3842 and a connectormember 3852 coupled to the marker band 3842. The connector member 3852can be similar to or the same as, for example, the connector membersdescribed above. For example, the connector member 3852 includes a wire3868 coupled to the marker band 3842 and an implant ball member 3870coupled to (or formed monolithically or integrally with) the wire 3868.

To insert and deploy the expandable implant 3810 within a patient'sbody, the expandable implant 3810 is first coupled to the insertiondevice 3854. Specifically, in this embodiment, the second elongatemember 3858 is moved proximally (in a direction of arrow A in FIG. 53)such that the distal end portion 3867 is moved proximally to a positionproximal of the inner stopper 3874. This allows the implant ball member3870 to be inserted through an opening in a distal end of the firstelongate member 3856 and into the lumen 3857 of the first elongatemember 3856. The second elongate member 3858 is then moved distally (inthe direction of arrow B in FIG. 53) such that the distal end portion3867 of the second elongate member 3856 engages the implant ball member3870 and traps or wedges the implant ball member 3870 within the lumen3857 of the first elongate member 3856 between the distal end portion3867 and the inner stopper 3874.

With the implant ball member 3870 locked or wedged within the lumen 3857of the first elongate member 3856, the expandable implant 3810 will beheld to the insertion device 3854. As described above for previousembodiments, a locking mechanism (not shown) can be coupled to thehandle and can be used to lock the second elongate member 3858 in thisposition relative to the first elongate member 3856. With the insertiondevice 3854 coupled to the expandable implant 3810, the expandableimplant 3810 can be inserted into, for example, an insertion cannula(not shown) (e.g., cannula 102 described above) to move the expandableimplant 3810 to a collapsed configuration, and the insertion cannula canbe used to insert the implant 3810 into a blood vessel in a similarmanner as described above with respect to previous embodiments.

After the expandable implant 3810 has been deployed within, for example,an aneurysm, the insertion device 3854 can be detached from theexpandable implant 3810 and removed from the patient's body.Specifically, to detach the insertion device 3854 from the expandableimplant 3810, the second elongate member 3858 is unlocked from thehandle and moved proximally (in the direction of arrow A) such that thedistal end portion 3867 is moved proximally and disengages the implantball member 3870. With the distal end portion 3867 moved proximally, theimplant ball member 3870 will be free to move outside of the lumen 3857of the first elongate member 3856. The insertion device 3854 can then beremoved by pulling the insertion device 3854 proximally.

FIG. 54 is a schematic illustration of another embodiment of aninsertion device that can be used to insert and deploy an implant, suchas an expandable implant as described herein. An insertion device 3954can be used in conjunction with a cannula or catheter, and can bereleasably or removably coupled to an implant, as described for previousembodiments.

The insertion device 3954 includes a first elongate member 3956, asecond elongate member 3958 and an outer shrink tube 3938. The firstelongate member 3956 defines a lumen 3957 through which the secondelongate member 3958 can be movably disposed and the shrink tube 3938and the first elongate member 3956 collectively define a lumen 3939 thatthe second elongate member 3958 can also be movably disposed within.

The first elongate member 3956 defines a skived or cutout portion 3953that extends between an intermediate portion 3959 of the first elongatemember 3956 and a distal end portion 3972 of the first elongate member3956. The outer shrink tube 3938 can be coupled to the first elongatemember 3956 at least along a portion of the first elongate member 3956that defines the skived portion 3953. The skived portion 3953 can reducethe mass of the first elongate member 3956 and allow the first elongatemember 3956 to be more flexible along the skived portion. The outershrink tube 3938 can be, for example, a material that is heat shrunk tothe outer surface of the first elongate member 3956 to provide an outerboundary or perimeter of the insertion device 3954 along the skivedportion 3953 of the first elongate member 3956. The outer shrink tube3938 can be formed with a flexible material such that the portion of thefirst elongate member 3956 including the skived portion 3953 and theouter shrink tube 3938 is flexible and can be maneuvered throughtortuous vasculature.

The distal end portion 3972 of the first elongate member 3956 defines aside window 3973 in fluid communication with a lumen 3937 defined by thedistal end portion 3972. One or more tab members 3951 (three shown inFIG. 54) are disposed on the first elongate member 3956 at spacedlocations along a length of the first elongate member 3956. The tabmembers 3951 can be, for example, semi-circular or c-shaped defining anopen portion or can be circular or ring shaped forming a closed loop.The tab members 3951 can be separate components coupled to the firstelongate member 3956 or formed integrally or monolithically with thefirst elongate member 3956. A sleeve member 3949 is coupled to one ofthe tab members 3951 and/or to the first elongate member 3956. Thesleeve member 3949 can be, for example, welded to the tab member 3951and/or the first elongate member 3956. The sleeve member 3949 defines alumen 3933 through which the second elongate member 3958 can be movablydisposed.

As shown in FIG. 54, the second elongate member 3958 can be movablydisposed through the lumen 3957, the lumen 3939, a lumen 3933 of thesleeve member 3949 and the lumen 3937 of the distal end portion 3972. Aninsertion ball member 3960 is disposed at a distal end of the secondelongate member 3958 and a bumper 3994 is coupled to the second elongatemember 3958 proximally of the insertion ball member 3960. In addition, astopper 3948 is coupled to the second elongate member 3958 at a spaceddistance proximal of the bumper 3994 and a radiopaque marker 3961 iscoupled to the second elongate member 3958 proximal of the stopper 3948.The bumper 3994, the stopper 3948 and the radiopaque marker 3961 caneach be, for example, welded to the second elongate member 3958. Theinsertion device 3954 can also include a handle (not shown) disposed ata proximal end portion of the insertion device 3954 as described abovefor previous embodiments.

As with previous embodiments, the insertion device 3954 can be coupledto an expandable implant 3910 similar to, or the same as, the expandableimplants described herein. In this embodiment, the expandable implant3910 includes a marker band 3942 at a proximal end portion, and aconnector member 3952 coupled to the marker band 3942. The connectormember 3952 can be similar to, or the same as, for example, theconnector members described above and includes a wire 3968 coupled tothe marker band 3942 and an implant ball member 3970 coupled to (orformed monolithically or integrally with) the wire 3968.

In use, to insert and deploy the expandable implant 3910 within apatient's body, the expandable implant 3910 is first coupled to theinsertion device 3954. Specifically, in this embodiment, the secondelongate member 3958 is moved proximally (in a direction of arrow A inFIG. 54) such that the insertion ball member 3960 is disposed proximallyof the window 3973 defined by the distal end portion 3972 of the firstelongate member 3956. This allows the implant ball member 3970 to beinserted through an opening 3963 defined at a distal end of the firstelongate member 3956 and into the lumen 3937 of the distal end portion3972 of the first elongate member 3956. For example, the insertion ballmember 3960 and the implant ball member 3970 can each be sized (e.g.,each can have a diameter) such that collectively the insertion ballmember 3960 and the implant ball member 3970 have a size (e.g., adiameter) greater than a diameter of the lumen 3937. Thus, the insertionball member 3960 is moved to a position proximal of the window 3973 toprovide clearance or space for the implant ball member 3970 to beinserted into the lumen 3937 and disposed near or adjacent to the window3973. With the implant ball member 3970 disposed near the window 3973,the second elongate member 3958 can then be moved distally (in adirection of arrow B in FIG. 54) such that the insertion ball member3960 is moved distally and contacts the implant ball member 3970, andmoves or pushes the implant ball member 3970 at least partially throughthe window 3973. The bumper 3994 provides rigidity to the distal portionof the second elongate member 3958 as the insertion ball member 3960 ismoved distally. The second elongate member 3958 is moved distally untilthe insertion ball member 3960 is moved to a position distal of theimplant ball member 3970, allowing the implant ball member 3970 to moveback at least partially within the lumen 3937. Further, as the secondelongate member 3958 is moved distally, the stopper 3948 on the secondelongate member 3958 can contact the sleeve member 3949 to limit themovement of the second elongate member 3958 in the distal direction.With the insertion ball member 3960 and the implant ball member 3970interlocked within the lumen 3937 and the implant ball member 3970 nowpositioned proximal of the insertion ball member 3960, the implant 3910is maintained coupled to the insertion device 3954.

With the implant ball member 3970 held or trapped within the lumen 3937of the distal end portion 3972, a locking mechanism (not shown) can beused to lock the second elongate member 3958 in this position relativeto the first elongate member 3956. For example, a locking mechanism canbe coupled to a handle (not shown) as described above for previousembodiments. With the insertion device 3954 coupled to the expandableimplant 3910, the expandable implant 3910 can be inserted into the lumenof an insertion cannula (not shown) to move the expandable implant 3910to a collapsed configuration. The insertion cannula can be used toinsert the implant 3910 into a blood vessel in a similar manner asdescribed above with respect to previous embodiments.

After the expandable implant 3910 has been deployed within, for example,an aneurysm, the insertion device 3954 can be detached from theexpandable implant 3910 and removed from the patient's body.Specifically, to detach the insertion device 3954 from the expandableimplant 3910, the second elongate member 3958 is moved proximally (inthe direction of arrow A) such that the insertion ball member 3960contacts the implant ball member 3970 and moves the implant ball member3970 at least partially through the window 3973. The second elongatemember 3958 is moved proximally until the insertion ball member 3960 isdisposed proximal of the window 3973 such that the implant ball member3970 can move back within the lumen 3937 of the distal end portion 3972.The sleeve member 3949 can limit the proximal movement of the secondelongate member 3958 by engaging the insertion ball member 3960. Forexample, the insertion ball member 3960 can have a larger diameter thanan inner diameter of the sleeve member 3949. With the implant ballmember 3970 disposed distal of the insertion ball member 3960, theimplant 3910 can be released from the insertion device 3954. Forexample, the insertion device 3954 can be removed by pulling theinsertion device 3954 proximally and as the insertion device 3954 ismoved proximally, the implant ball member 3970 can move through thedistal opening 3963 leaving the implant 3910 implanted within thepatient's body.

FIGS. 55 and 56 illustrate another embodiment of an insertion device. Aninsertion device 4054 includes a first elongate member 4056, a secondelongate member 4058 and an outer shrink tube 4038. The first elongatemember 4056 defines a lumen (not shown) through which the secondelongate member 4058 can be movably disposed and the shrink tube 4038and the first elongate member 4056 collectively define a lumen (notshown) that the second elongate member 4058 can also be movably disposedwithin. The insertion device 4054 can be used in conjunction with acannula or catheter, and can be releasably or removably coupled to animplant, as described for previous embodiments.

The first elongate member 4056 defines a skived or cutout portion 4053that extends between an intermediate portion 4059 of the first elongatemember 4056 and a distal end portion 4072 of the first elongate member4056. The first elongate member 4056 can also include additional skivedor cutout portions (not shown). The outer shrink tube 4038 can becoupled to the first elongate member 4056 at least along a portion ofthe first elongate member 4056 that defines the skived portion 4053. Theskived portion 4053 can reduce the mass of the first elongate member4056 and allow the first elongate member 4056 to be more flexible alongthe skived portion. The outer shrink tube 4038 can be, for example, amaterial that is heat shrunk to the outer surface of the first elongatemember 4056 to provide an outer boundary or perimeter of the insertiondevice 4054 along the skived portion 4053 of the first elongate member4056. The outer shrink tube 4038 can be formed with a flexible materialsuch that the portion of the first elongate member 4056 including theskived portion 4053 and the outer shrink tune 4038 is flexible and canbe maneuvered through tortuous vasculature.

The distal end portion 4072 of the first elongate member 4056 defines aside window 4073 and a lumen (not shown) in fluid communication with theside window 4073. One or more tab members 4051 (only one tab member isshown in FIGS. 55 and 56) are disposed on the first elongate member 4056at spaced locations along a length of the first elongate member 4056. Asshown in FIGS. 55 and 56, in this embodiment, the tab member 4051 issubstantially c-shaped defining an open portion. The tab member 4051 canbe, for example welded to the first elongate member 4056.

As shown in FIGS. 55 and 56, the second elongate member 4058 can bemovably disposed through the lumen of the first elongate member 4056,the lumen defined collectively by the first elongate member 4056 and theouter shrink tube 4038, and the lumen of the distal end portion 4072. Aninsertion ball member (not shown) is disposed at a distal end of thesecond elongate member 4058 and a bumper 4094 is coupled to the secondelongate member 4058 proximally of the insertion ball member. As shownin FIGS. 55 and 56, in this embodiment, the bumper 4094 includes aspring. In addition, a stopper (not shown) and a radiopaque marker (notshown) can be coupled to the second elongate member 4058 at a spaceddistance proximal of the bumper 4094 as with the previous embodiments,and can provide the same function as described above for insertiondevice 3954. The insertion device 4054 can also include a handle (notshown) disposed at a proximal end portion of the insertion device 4054as described above for previous embodiments. The bumper 4094, thestopper and the radiopaque marker can each be, for example, welded tothe second elongate member 4058.

As with previous embodiments, the insertion device 4054 can be coupledto an expandable implant 4010 similar to, or the same as, the expandableimplants described herein. The expandable implant 4010 includes a markerband 4042 at a proximal end portion, and a connector member 4052 coupledto the marker band 4042, The connector member 4052 includes a wire 4068coupled to the marker band 4042 and an implant ball member 4070 (seeFIG. 56) coupled to (or formed monolithically or integrally with) thewire 4068. FIG. 56 illustrates the implant ball member 4070 insertedinto the distal end portion 4072 of the first elongate member 4056 anddisposed near the window 4073.

In use, the insertion device 4054 can function the same as or similar tothe insertion device 3954 described above. For example, the implant 4010can be coupled to the insertion device 4054 and locked in position bythe insertion ball member in the same or similar manner as describedabove for insertion device 3954. Likewise, the implant 4010 can bereleased from the insertion device 4054 in the same or similar manner asdescribed above for insertion device 3954.

FIG. 57 illustrates another embodiment of a medical device that includesa lead-in portion or member disposed at a distal end portion of anexpandable implant. The medical device 4100 includes an expandableimplant 4110 that can be configured the same as or similar to any of theembodiments of an expandable implant described herein. For example, theexpandable implant 4110 can be deployed within an aneurysm of a patientas described herein. As shown in FIG. 57, a lead-in member 4176 iscoupled to a distal end portion of the expandable implant 4110. In thisembodiment, the lead-in member 4176 is coupled to the distal end portionof the expandable implant 4110 with a crimp 4178. The lead-in member4176 can be formed with, for example a shape memory material such, asnitinol, such that the lead-in member 4176 has a biased curved shapewhen not constrained within, for example a cannula 4105. Thus, thelead-in member 4176 can provide a smooth surface free of sharp edgeswhen inserting the expandable implant 4110 within a vasculature of apatient. The lead-in member 4176 can have a substantially linearconfiguration when constrained within the cannula 4105, or a deliverydevice as described herein. Although not shown in FIG. 57, the medicaldevice 4100 can be delivered within a vasculature of a patient using adelivery device as described herein for other embodiments.

FIGS. 58-60 illustrate a portion of a medical device 4200 according toan embodiment. The medical device 4200 can include the same or similarfeatures and functions as described herein for other embodiments. Forexample, the medical device 4200 can include an expandable implant 4210configured to move from the collapsed configuration (e.g., for deliverythrough a blood vessel) to the expanded configuration (e.g., fordeployment within an aneurysm) and an insertion member or device 4254(shown in FIG. 59) as described herein.

Similar to the expandable implant 1810, the expandable implant 4210includes a ribbon-like strand of porous mesh that includes one or morepetal-like portions or sections 4225 along its length. In thisembodiment, there are four petal-like portions 4225 included within anouter petal segment 4291 of the expandable implant 4210 and threepetal-like portions 4225 included within an inner petal segment 4290 ofthe expandable implant 4210.

At least a portion of the porous mesh can be configured to be positionedover a neck of an aneurysm when the expandable implant 4210 is in theexpanded configuration. When the expandable implant 4210 is in itsexpanded configuration, the expandable implant 4210 has athree-dimensional shape (e.g., a substantially spherical shape) with asubstantially continuous outer surface such that a portion (e.g., edges)of at least two of the petal-like portions 4225 overlap each other asshown in FIG. 59. For example, as the expandable implant 4210 is beingdeployed within an aneurysm, the petal-like portions 4225 of the outerpetal segment 4191 expands first and forms an outer layer that coversthe aneurysm. The petal-like portions 4225 of the inner petal segment4290 then form a second spherical layer of material inside thepetal-like portions 4225 of the outer petal portion 4291 to providegreater surface area to further promote thrombosis.

In this embodiment, a suture strand 4235 extends along the length of theexpandable implant 4210 to provide reinforcement to the expandableimplant 4210 and can also provide for a radiopaque coil to be disposedover at least a portion of the suture strand 4235 to provide visibilityof the expandable implant 4210 during, for example, fluoroscopy. Asshown in FIGS. 58 and 59, the suture strand 4235 is disposed along alength of the expandable implant 4210 and across or within thepetal-like portions 4225. The suture strand 4235 can be coupled to, forexample, marker bands 4242 and 4244 disposed on a proximal end and adistal end, respectively, of the expandable implant 4210.

In this embodiment, the outer petal segment 4291 and the inner petalsegment 4290 can be formed as separate components and coupled togetherby the suture strand 4235. This creates an articulation point or joint4279 between the outer petal segment 4291 and the inner petal segment4290. For example, the inner petal segment 4290 can include the markerband 4242 at a proximal end and a marker band 4294 at a distal end. Theouter petal segment 4291 can include the marker band 4244 at a distalend and a marker band 4295 at a proximal end. The articulation joint4279 is defined where the marker band 4294 and the marker band 4295 arecoupled to the suture strand 4235.

The articulation joint 4279 can provides greater freedom of motion ofthe petal-like portions 4225, which can allow more uniform expansion ofthe petal-like portions 4225. In 4290, the separate construction of theouter petal segment 4291 and the inner petal segment 4290 can allow forone spherical layer of the expandable implant to be formed at a time,which may be advantageous and/or easier to manufacture. The ability tomanufacture the expandable implant 4210 in multiple segments can alsoallow for the addition to, or removal of, segments of an expandableimplant to provide a selected length or size of the expandable implantto meet a particular need.

As shown in FIG. 58, the expandable implant 4210 can also include alead-in member 4276 coupled to a distal end portion of the expandableimplant 4210 with the marker band 4244. The lead-in member 4276 can beformed with, for example a shape memory material such, as nitinol, suchthat the lead-in member 4276 has a biased curved shape when notconstrained within, for example a cannula (not shown) as described abovefor expandable implant 4110. In some embodiments, the lead-in member4276 can be coupled to the distal end portion of the expandable implant4210 with a crimp similar to the implant 4110. Although not shown, theexpandable implant 4210 can also include a coupling member to releasablycouple the expandable implant 4210 to the delivery device 4254 asdescribed above for previous embodiments.

FIG. 60 illustrates another embodiment of a medical device 4300 thatincludes an expandable implant 4310 that has multiple articulationjoints 4379. The medical device 4300 can include the same or similarfeatures and functions as described herein for other embodiments. Forexample, the medical device 4300 can be configured to move from acollapsed configuration a shown in FIG. 60 (e.g., for delivery through ablood vessel) to an expanded configuration (not shown) (e.g., fordeployment within an aneurysm). The medical device 4300 can also includean insertion member or device (not shown in FIG. 60) to which theexpandable implant 4310 can be releasably coupled, as described abovefor previous embodiments.

The expandable implant 4310 includes a ribbon-like strand of porous meshthat includes one or more petal-like portions or sections 4325 along itslength. In this embodiment, there are three petal-like portions 4325included within a first petal segment 4392 of the expandable implant4310, four petal-like portions 4325 included within a second petalsegment 4391, and three petal-like portions 4325 included within a thirdpetal segment 4390 of the expandable implant 4310.

As with the previous embodiment, at least a portion of the porous meshcan be configured to be positioned over a neck of an aneurysm when theexpandable implant 4310 is in the expanded configuration. When theexpandable implant 4310 is in its expanded configuration, the expandableimplant 4310 can have a three-dimensional shape (e.g., a substantiallyspherical shape) with a substantially continuous outer surface asdescribed above for previous embodiments.

A suture strand 4335 extends along the length of the expandable implant4310 to provide reinforcement to the expandable implant 4310 and canalso provide for a radiopaque coil to be disposed over at least aportion of the suture strand 4335 to provide visibility of theexpandable implant 4310 during, for example, fluoroscopy. The suturestrand 4335 can be coupled to, for example, marker bands 4342 and 4344disposed on a proximal end and a distal end, respectively, of theexpandable implant 4310.

As shown in FIG. 60, the expandable implant 4310 can also include alead-in member 4376 coupled to a distal end portion of the expandableimplant 4310 with the marker band 4344. The lead-in member 4376 can beformed the same as or similar to the lead-in members described above.Although not shown, the expandable implant 4310 can also include acoupling member to releasably couple the expandable implant 4310 to adelivery device as described above for previous embodiments.

In this embodiment, the first petal segment 4392, the second petalsegment 4391 and the third petal segment 4390 can be formed as separatecomponents and coupled together by the suture strand 4335. This createsa first articulation point or joint 4379 between the first petal segment4392 and the second petal segment 4391, and a second articulation pointor joint 4379′ between the second petal segment 4391 and the third petalsegment 4390. In this embodiment, the first petal segment 4392 includesthe marker band 4344 on a distal end and a marker band 4397 on aproximal end, the second petal segment 4391 includes a marker band 4396on a distal end and a marker band 4395 on a proximal end, and the thirdpetal segment 4390 includes the marker band 4342 at a proximal end and amarker band 4394 at a distal end. The first articulation joint 4379 isdefined where the marker band 4397 and the marker band 4396 are coupledto the suture strand 4335, and the second articulation joint 4379′ isdefined where the marker band 4395 and the marker band 4394 are coupleto the suture strand 4335.

As discussed above for expandable implant 4210, the articulation joints4379, 4379′ can provide greater freedom of motion of the petal-likeportions 4325 of the expandable implant 4310, which can allow moreuniform expansion of the petal-like portions 4325 within an aneurysm. Inaddition, with three petal segments 4392, 4391, 4390, the expandableimplant 4310 can have a greater density when deployed within an aneurysmwhich can further enhance thrombosis.

In alternative embodiments, an expandable implant can have a differentnumber of articulation joints and a different number of petal segmentsthan described above for expandable implants 4210 and 4310. In someembodiments, it may be desirable to have at least two petal-likeportions (e.g., 4225, 4325) between the articulation joints. In otherwords it may be desirable for each petal segment to have at least twopetal-like portions. A greater number of articulation points or jointscan provide increased freedom of motion of the petal-like portions,which can lead to a more uniform expansion of the expandable implant.The petal segments or layers can also have variable stiffness. Forexample, in an expandable implant, such as, expandable implant 4310, itmay be desirable for the first petal segment to have a greater stiffnesssuch that the first petal segment (e.g., petal segment 4392) can framethe aneurysm as the expandable implant is being deployed within theaneurysm. In this example it may be desirable for the second petalsegment (e.g., petal layer 4391) to have a medium stiffness (e.g.,stiffness less than the first petal segment and greater than the thirdpetal segment) to fill the aneurysm, and the third petal segment (e.g.,petal segment 4390) to be the softest segment to pack the aneurysm.

The petal width can also be varied between segments. For example, it maybe desirable for the distal segment (e.g., first petal segment 4392) tohave a greater width than the remaining segments and the proximal petalsegments (e.g., the second petal segment 4391 and/or the third petalsegment 4390) to be shorter and narrower to fit inside the distalsegment (e.g., the first petal segment 4392).

The insertion devices (e.g., 2554, 2654, 2754, 2854, 3254, 3354, 3454,3554, 3654, 3754, 3854, 3954, 4054) described herein can be used todeliver an expandable implant as described herein. For example, any ofthe expandable implants described herein can include an outer markerband and an inner marker band coupled to a proximal end portion of theexpandable implant that can be used to couple the expandable implant toan insertion device, such as, for example, the insertion devices 2554,2654 and 2754. In addition, any of the expandable implants describedherein can include a connector member (e.g., 1652, 1952, 2452, 2852,3252, 3352, 3452, 3552, 3652, 3752, 3852, 3952, 4052) as describedabove, including a wire and ball member configured to be coupled to aninsertion device, such as, for example, insertion devices 2854, 3254,3354, 3454, 3554, 3654, 3754, 3854, 3954 and 4054. Further, although theball members (insertion or implant ball members) are shown as circular,any of the ball members described herein can be other shapes, such as,for example, oval, elliptical, square, rectangular, triangular or otherdesired shape (as shown in a side view).

The various devices described herein can be made of any materialsuitable for the defined purpose, including, for example, drawn filledtube DFT®. DFT is available as wire, cable or ribbon. DFT is ametal-to-metal composite developed to combine the desired physical andmechanical attributes of two or more materials into a single wire orribbon system, which can be used for the expandable implant.

Filaments or wires for the braid or mesh (e.g., the expandable implants)can include, for example, filaments of materials such as MP35N,stainless steel, nitinol, cobalt chromium, titanium, platinum, tantalum,tungsten, or alloys thereof, or polyester, polyethylene (PET), Dacron,PEEK, vectron, and suture materials. Each strand may have a diameterbetween 0.0005″-0.010″, e.g., about 0.002″. In some embodiments, anouter material of the mesh or braid can be formed with nitinol that issuperelastic at body temperature, and an inner material can beradiopaque, or alternatively platinum wires may be included in the braidto provide additional radiopacity. For example, in some embodiments, anexpandable implant can include radiopaque material(s) woven within themesh material such that the expandable implant can be highly visiblewithout the use of a radioactive die.

Suitable materials can be chosen based on their electropositivity. Forexample, an expandable implant can include titanium, tungsten, oranother material listed below in Table 1, or any combination thereof. Inuse, the electropositive material of the expanded expandable implantcreates an electrically favorable region within the vascular defect andthrough the blood, and the region in the defect containing blood, fluidor tissue is then predisposed for endothelialization to occur.

TABLE 1 PERIODIC COMPOSITE TABLE CHARGE ELEMENT ABBREVIATION FULL NAMEVALUE 22 Ti titanium 1.36 23 V vanadium 1.53 40 Zr zirconium 1.22 41 Nbniobium or 1.33 columbium 42 Mo molybdenum 1.47 72 Hf hafnium 1.16 73 Tatantalum 1.30 74 W tungsten 1.47

In some embodiments, the expandable implants described herein can beformed with tubular braid, or sheets of woven filaments (forming a mesh,weave or fabric). The filaments can be wire or polymer or other suitablematerial. The expandable implants can be braided wire (e.g. NiTi wire),and can include a mixture of wire types and wire sizes (e.g. NiTi andPlatinum wire, and e.g. 0.001″ wire braided with 0.00125″ wire). Theexpandable implants can also be made with polymer fibers, or polymerfibers and metal wire mixed together. In some embodiments, the filamentsor wires for the braid or mesh can be formed with a radiopaque material.In some embodiments, the filaments or wires for the braid or mesh caninclude, for example, a wire coextruded with a platinum core surroundedby nitinol (NiTi). In other words, the wire includes two concentriccircles when viewed in a cross-sectional view, with the center or corewire being platinum, and the outer wire being nitinol. The percentage ofplatinum can be, for example, between 5% platinum to 50% platinum andseveral variations in between (e.g., 10%, 15%, 20%, 25%, 30%, 35%, 40%,45%). Said another way, a percentage of a diameter of the wire can be,for example 5% to 50% platinum. In some embodiments, the percentage ofplatinum to nitinol is 30% platinum and 70% nitinol. In someembodiments, the expandable implants can be formed with one or morebioabsorbable materials. In some embodiments, after the expandableimplant is formed, the mesh of the implant can be etched to remove anouter oxide layer. This can provide corrosion reduction and/or helpthrombosis form faster.

The expandable implants described herein can be formed with one or moresoft pliable materials such that the expandable implant can be deployed,for example, in a ruptured or unruptured aneurysm. In some embodimentsan expandable implant as described herein can be formed with one or morematerials such that the expandable implant has variable stiffness. Forexample, a first portion of the expandable implant can be formed with afirst material and a second portion of the expandable implant can beformed with a second material different than the first material, or thefirst material can have a different thickness than the second material.For example, in some embodiments, a distal end portion of the expandableimplant can be formed with a first material and a proximal end portionof the expandable implant can be formed with a second material differentthan the first material. In some embodiments, a proximal end portion ofan expandable implant can be formed with a first material that providesfor greater stiffness than a second material with which a distal endportion of the expandable implant is formed. Such an embodiment may bedesirable such that the softer distal end portion of the implant can bedeployed within an aneurysm and the stiffer proximal end portion canprovide more structure to help support the implant at, for example, aneck of the aneurysm.

The mesh of the expandable implants can be made by a variety ofdifferent forms, including, but not limited to, braiding, weaving,welding, or laser cutting. The mesh can have an operating length, forexample, in a range of about 0.5 cm to about 70 cm. In some embodiments,the mesh can have a length of 30 cm. In some embodiments, the mesh canhave a diameter in a range of about 0.5-60 mm. In some embodiments, themesh can have a diameter of up to about 10 mm when expanded (e.g., about9.5 mm for an outer porous member or portion, about 8 mm for an innerporous member or portion). The mesh can have a single density or canhave two or more densities. For example, in some embodiments, the numberof variable densities can be in a range of about 2 to about 10. Forexample, a first density can be about 100 PPI and a second density canbe about 40 PPI (PPI=pies per inch). The braid pattern can be anypattern suitable, for example, a one-over-one configuration, ortwo-over-one configuration, etc. Strand count for the mesh can be in arange of about 4 strands to about 288 strands. In some embodiments, thestrand count is about 48 strands. Common multiples of 4, 8, 16, 24, 32,64, 72, 96, 128, 144, 192 and 288 strands for braid are available usingcommercial braiders.

A single expandable implant can include wires of the same size or acombination of 2 different wire sizes. For example, the expandableimplant can have 24 wires of 0.001″ and 24 wires of 0.0005″. The thickerwires can impart additional strength to the expandable implant and thethinner wire can provide density. In addition, any combination of wirecount, wire diameter, braid angle or pics per inch can be used to makethe mesh of the expandable implant.

CONCLUSION

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly, and not limitation. Where methods and steps described aboveindicate certain events occurring in certain order, those of ordinaryskill in the art having the benefit of this disclosure would recognizethat the ordering of certain steps may be modified and that suchmodifications are in accordance with the variations of the invention.Additionally, certain of the steps may be performed concurrently in aparallel process when possible, as well as performed sequentially asdescribed above. For example, the expandable implant can be insertedinto the catheter concurrently with positioning of the expandablecatheter adjacent the aneurysm.

The embodiments have been particularly shown and described, but it willbe understood that various changes in form and details may be made. Forexample, although various embodiments have been described as havingparticular features and/or combinations of components, other embodimentsare possible having any combination or sub-combination of any featuresand/or components from any of the embodiments described herein. Thespecific configurations of the various components can also be varied.

For example, although the embodiments (e.g., medical device 1010)illustrated and described herein include one or two porous members orportions (e.g., porous members 1020, 1030), in other embodiments, anysuitable number of porous members or portions can be included. Forexample, in some embodiments, the medical device 1010 can also include athird porous member (not shown) having a first end and a second end andcoupled to at least one of the first porous member 1020 and the secondporous member 1030. Like the first and second porous members 1020, 1030,the third porous member can have a collapsed configuration for insertionthrough the blood vessel and an expanded configuration for occupying thesac of the aneurysm. The third porous member can be substantiallyelongate and have a width in its expanded configuration that is greaterthan its width in its collapsed configuration.

In another example, a radiopaque marker of a medical device illustratedand described can be differently positioned on an expandable implant ofthe medical device. Moreover, the size and specific shape of the variouscomponents can be different than the embodiments shown, while stillproviding the functions as described herein.

We claim:
 1. An occlusive device configured to be positioned within ananeurysm, the device comprising: a mesh component having first andsecond ends and a broad portion therebetween, the mesh component havinga preset shape such that, at least when the mesh component is in adeployed state, the mesh component includes a broad portion comprising alongitudinally flattened tubular mesh, the broad portion having a widththat tapers in the direction of the first end; a suture strand coupledto, and extending proximally from, the mesh component; a coil disposedover the suture strand and extending proximally from the mesh component;and a lead-in member coupled to the second end of the mesh component. 2.The occlusive device of claim 1, wherein the width of the broad portionfurther tapers in the direction of the second end.
 3. The occlusivedevice of claim 1, wherein the mesh component comprises a braid.
 4. Theocclusive device of claim 3, wherein the braid comprises superelasticmaterials.
 5. The occlusive device of claim 3, wherein the meshcomponent comprises a flattened tubular braid.
 6. The occlusive deviceof claim 1, wherein the braid is formed of a plurality of drawn-filledtube (“DFT”) wires.
 7. The occlusive device of claim 6, wherein each ofthe DFT wires comprises a platinum core surrounded by an outer nitinollayer.
 8. The occlusive device of claim 1, wherein the mesh componentcomprises a petal-shaped portion.
 9. The occlusive device of claim 1,wherein the mesh component is configured to be positioned across a neckof the aneurysm to cover the neck of the aneurysm and substantiallyreduce or prevent blood flow into the aneurysm.
 10. The occlusive deviceof claim 1, wherein the mesh component is configured to be positionedacross a neck of the aneurysm such that the mesh component serves as ascaffold for endothelial cell attachment to promote endothelization ofthe neck.
 11. The occlusive device of claim 1, wherein the suture strandis configured to provide an articulation joint at the first end of themesh component.
 12. The occlusive device of claim 1, wherein the coil isradiopaque.
 13. The occlusive device of claim 1 wherein the lead-inmember has a biased curved shape.
 14. The occlusive device of claim 1,further comprising a respective marker band at one or more of the firstend and the second end of the mesh component.
 15. The occlusive deviceof claim 14, wherein the respective marker band is radiopaque.
 16. Anocclusive device configured to be positioned within an aneurysm, thedevice comprising: a mesh component comprising at least one petal-shapedportion having first and second tapered ends and a broad portiontherebetween, the broad portion comprising a longitudinally flattenedtubular mesh having a width that narrows at each of the first and secondends; a suture strand coupled to, and extending proximally from, themesh component; a coil disposed over the suture strand and extendingproximally from the mesh component; and a lead-in member coupled to thesecond end of the mesh component.
 17. The occlusive device of claim 16,wherein the petal-shaped portion is a braid.
 18. The occlusive device ofclaim 16, wherein the petal-shaped portion is a flattened tubular braid.19. The occlusive device of claim 16, wherein the petal shaped portionis a braid comprising superelastic materials.
 20. The occlusive deviceof claim 16, wherein the petal-shaped portion is a braid formed of aplurality of DFT wires.
 21. The occlusive device of claim 20, whereineach of the DFT wires comprises a platinum core surrounded by an outernitinol layer.
 22. The occlusive device of claim 16, wherein the meshcomponent is configured to be positioned across a neck of the aneurysmto cover the neck of the aneurysm and substantially reduce or preventblood flow into the aneurysm.
 23. The occlusive device of claim 16,wherein the mesh component is configured to be positioned across a neckof the aneurysm such that the mesh component serves as a scaffold forendothelial cell attachment to promote endothelization of the neck.